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  • General dilution charts -- Format and content of intravenous medications -- Key to abbreviations -- Important IV therapy facts -- Resources -- IV drugs -- Appendix A: Recommendations for the safe use and handling of cytotoxic drugs -- Appendix B: FDA pregnancy categories) -- Appendix C: U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute Common Terminology Criteria for adverse events (CTCAE) -- Appendix D: Information for patients receiving immunosuppressive agents -- Appendix E: Recently approved drugs -- Solution compatibility chart.
  • Advances in antiepileptic drug development / Philip N. Patsalos -- Current guidelines and standard treatments / Dieter Schmidt & G{uml}unter Kr{uml}amer -- Advances in screening models for identifying new antiepileptic drugs / Kinga K. Borowicz & Stanislaw J. Czuczwar -- New antiepileptic drugs : advances in pharmacokinetics, drug interaction and adverse effect profiles / Domenico Italiano & Edoardo Spina -- Antiepileptic drugs in clinical trials and future direction / Alberto Verrotti, Chiara Cirillo & Giulia Loiacono.
  • Pt. 1. Target organ toxicity. -- Drug-induced liver injury / Michael Holt, Cynthia Ju.-- Drug herpersensitivity reactions involving skin / Oliver Hausmann, Benno Schnyder, Werner J. Pichler.-- Adverse drug reactions affecting blood cells / Richard H. Aster.-- Molecular mechanisms of adverse drug reactions in cardiac tissue / Reza Tabrizchi.-- Mechanisms of drug-induced nephrotoxicity / Thomas D. Nolin, Jonathan Himmelfarb.-- Receptor- and reactive intermediate-mediated mechanisms of teratogenesis / Peter G. Wells, Crystal J.J. Lee, Gordon P. McCallum, Julia Perstin, Patricia A. Harper.-- Pt. II. Mediators/Biochemical pathways.-- Role of reactive metabolites in drug-induced hepatotoxicity / A.M. Srivastava, J. L. Maggs, D. J. Antoine, D. P. Williams, D. A. Smith, B. K. Park.-- Role of cytokines in the mechanism of adverse drug reactions / Mary Jane Masson, Lindsay A. Collins, Lance R. Poh.-- Keap1-Nrf2 cellular defense pathway: mechanisms of regulation and role in protection against drug-induced toxicity / Ian M. Copple, Christopher E. Goldring, Neil R. Kitteringham, B. Kevin Park.-- Signal transduction pathways involved in drug-induced liver injury / Derick Han, Mie Shinohara, Maria D. Ybanez, Behnam Saberi, Neil Kaplowitz.-- Mictrochondrial involvement in drug-induced liver injury / Dominique Pessayre, Abdellah Mansouri, Alain Berson, Bernard Fromenty.-- Pt. III. Examples/Models.-- Mechanisms of acetaminophen-induced liver necrosis / Jack A. Hinson, Dean W. Roberts, Laura P. James.-- Drug-induced liver injury in humans: the case of Ximelagtran / M. Keisu, T.B. Andersson.-- Troglitazone / Tsuyoshi Yokoi.-- Neviropine hypersensitivity / M. Popovic, J.M. Shenton, J. Chen, A. Baban, T. Tharmanathan, B. Mannargudi, D. Abdulla, J.P. Uetrecht.-- Mechanisms of adverse drug reactions to biologics / Janet B. Clarke.-- Pt. IV. Risk factors/Screening drug candidates.-- Pharmacogenetics of idiosyncratic adverse drug reactions / Munir Pirmohamed.-- Danger hypothesis applied to idiosyncratic drug reactions / Jinze Li, Jack P. Uetrecht.-- Approaches for minimizing metabolic activation of new drug candidates in drug discovery / Sanjeev Kumar, Kaushik Mitra, Kelem Kassahun, Thomas A. Baillie.
  • This monograph gathers and evaluates data on adverse events (AEs) associated specifically with those 'biomedicines' - monoclonal antibodies, fusion proteins, and cytokines - that have recently entered therapeutic use in humans. All AEs observed when using each member of this new drug class are covered, with a view to improving understanding of pathogenesis, facilitating prevention, monitoring, and control, and contributing to the development of better drugs that provide benefits while minimizing risk. Further aspects here examined include the role of drug mechanisms of action and immunogenicity in relation to AEs outcome and induction of systemic syndromes. Additional data on AEs in off-label treatments are also considered. Electronic data sheets, downloadable from the Springer Extra Materials platform, include more detailed safety data as well as additional basic information on product characteristics, pre- and post-marketing AEs classified according to frequency, and system/organ targeting. Data on excipients and selected information on drug interactions and associations are also provided. Adverse Events with Biomedicines: Prevention Through Understanding will serve as a detailed, practical guideline to this important new area, which demands the attention of clinicians, immunologists, oncologists, allergologists, public health professionals, and drug companies.
  • This book is a major update of novel targets in angiogenesis modulation, including pro- and anti-angiogenesis. There is in-depth coverage of preclinical and clinical methods and models, investigational status, and clinical applications. The impact of nanotechnology in advancing the applications of pro-and anti-angiogenesis strategies is also highlighted, along with stem cell and biotechnologies in research and development of angiogenesis modulating targets.
  • Part 1. Considerations with antibiotic therapy -- Part 2. Antibacterial drugs -- Part 3. Antimycobacterial drugs -- Part 4. Antifungal drugs -- Part 5. Antiviral drugs -- Part 6. Antiparasitic Drugs -- Appendix 1. Selected normal human flora -- Appendix 2. Spectrum of activity -- Appendix 3. Empiric regimens for common infections -- Index.
  • Since penicillin and salvarsan were discovered, a number of new drugs to combat infectious diseases have been developed, but at the same time, the number of multi-resistant microorganism strains is increasing. Thus, the design of new and effective antibacterial, antiviral and antifungal agents will be a major challenge in the next years. This book reviews the current state-of-the-art in antimicrobial research and discusses new strategies for the design and discovery of novel therapies. Topics covered include the use of genetic engineering, genome mining, manipulation of gene clusters, X-ray and neutron scattering as well as the antimicrobial effects of essential oils, antimicrobial agents of plant origin, beta-lactam antibiotics, antimicrobial peptides, and cell-wall-affecting antifungal antibiotics.
  • Omics & microarrays revisited -- The commercial microarrays -- Supports & surface chemistries -- The arraying processes -- Gene expression microarray-based applications -- Protein microarray applications -- Multiplex assays.
  • Print Material
  • ch. 1. Nitrilases and nitrile hydratases / Robert DiCosimo -- ch. 2. Biocatalytic deracemization : dynamic resolution, stereoinversion, enantioconvergent processes, and cyclic deracemization / Yolanda Simeo, Wolfgang Kroutil, and Kurt Faber -- ch. 3. A decade of biocatalysis at Glaxo Wellcome / Mahmoud Mahmoudian -- ch. 4. Biocatalysis for synthesis for chiral pharamaceutical intermediates / Ramesh N. Patel -- ch. 5. Directed evolution of lipases and esterases for organic synthesis / Aurelio Hidalgo and Uwe T. Bornscheuer -- ch. 6. Flavin-containing oxidative biocatalysts / Marco W. Fraaije and Willem J.H. van Berkel -- ch. 7. Preparation of chiral pharmaceuticals through enzymatic acylation of alcohols and amines / Vicente Gotor-Fernandez, Francisca Rebolledo, and Vicente Gotor -- ch. 8. Dynamic kinetic resolution and asymmetric transformations by enzyme-metal combinations / Mahn-Joo Kim, Yangsoo Ahn, and Jaiwook Park -- ch. 9. Biotransformation of natural or synthetic compounds for the generation of molecular diversity / Robert Azerad -- ch. 10. Applications of aromatic hydrocarbon dioxygenases / Rebecca E. Parales and Sol M. Resnick -- ch. 11. A genomic approach to investigating baker's yeast reductions / Jon D. Stewart -- ch. 12. Immobilization of enzymes as cross-linked enzyme aggregates : a simple method for improving performance / Roger A. Sheldon -- ch. 13. Biotechnological applications of aldolases / Wolf-Dieter Fessner and Stefan Jennewein -- ch. 14. Enzymatic synthesis of modified nucleosides / Luis A. Condezo ... [et al.] -- ch. 15. Biocatalytic reduction of carbozylic acids : mechanism and applications / Padmesh Venkitasubramanian, Lacy Daniels, and John P.N. Rosazza -- ch. 16. Dehalogenases in biodegradation and biocatalysis / Dick B. Janssen -- ch. 17. Enzymatic synthesis of sugar esters and oligosaccharides from renewable resources / A. Ballestros ... [et al.] -- ch. 18. Efficient methods and instrumentation for engineering custom enzymes / Steven J. Robles, William J. Coleman, and Mary M. Yang -- ch. 19. Deaminating enzymes of the purine cycle as biocatalysts for chemoezymatic synthesis and transformation of antiviral agents structurally related to purine nucleosides / Enzo Santaniello, Pierangela Ciuffreda, and Laura Alessandrini -- ch. 20. Mircobial and enzymatic processes for the production of chiral compounds / Kohsuke Honda ... [et al.] -- ch. 21. Discovery of arylmalonate decarbozylase and conversion of the function by rational design / Kenji Miyamoto and Hiromichi Ohta -- ch. 22. Chemoenzymatic preparation of enantiopure building blocks of synthetic utility / Kenji Mori -- ch. 23. Stereoselective modifications of polyhydorxylated steroids / Elena Fossati and Sergio Riva -- ch. 24. Recent developments in enzymatic acyloin condensations / Owen Ward and Ajay Singh -- ch. 25. Synthesis of chiral alcohols with carbonyl reductase library and robust NAD(P)H regenerating system / Hiroaki Yamamoto and Akinobu Matsuyama -- ch. 26. Comparative analysis of chemical and biocatalyic syntheses of drug intermediates / Michael J. Homann ... [et al.] -- ch. 27. Industrial processes using lyases fo C-C, C-N, and C-O bond formation / Martina Pohl an Andreas Lieses -- ch. 28. State of the art and applications in stereoselective synthesis of chiral cyanohydrins / Franz Effenberger, Siegfried Forster, and Christoph Kobler -- ch. 29. Chiral switches : problems, strategies, opportunities, and experiences / Rene Csuk -- ch. 30. Enzyme evolution for chemical process applications / Gjalt W. Huisman and James J. Lalonde -- ch. 31. Biocatalytic routes to nonracemic chiral amines / Nicholas J. Turner and Reuban Carr -- ch. 32. Enantioselective biocatalytic reduction of ketones for the synthesis of optically active alcohols / Stefan Buchholz and Harald Groger -- ch. 33. Enyzmes catalysis in nonaqueous media : past, present and future / Susanne Dreyer ... [et al.] -- ch. 34. Biocatalyic concepts for the synthesis of optically active amines / Stefan Buchholz and Harald Groger.
  • "... provides an established, recognized, authoritative and comprehensive source on medicinal chemistry and drug discovery and development. This flagship reference for medicinal chemists and pharmaceutical professions has been thoroughly updated and expanded across 8 volumes to incorporate the entire process of drug development (preclinical testing, clinical trials, etc.) alongside the traditional strengths in medicinal chemistry and drug discovery"--Provided by publisher.
  • A Time Travel Journey Through Cancer Therapies -- Nanotechnology for Cancer Treatment: Possibilities & Limitations -- Vascular Targeting Approaches to Treat Cancer -- Tumor Immunotherapy by Utilizing a Double-Edged Sword Chemokines -- Cancer Biology: Some Causes for a Variety of Different Diseases -- Cancer Stromal Targeting (CAST) Therapy and Tailored Antibody Drug Conjugate Therapy Depending on Nature of Tumor Stroma -- Cancer Cell Respiration: Hypoxia and pH in Solid Tumors -- Tumor Vasculature, EPR Effect, and Anticancer Nanomedicine: Connecting the Dots -- Pressure Gradients in Solid Tumors -- The ADAMs: New Therapeutic Targets for Cancer? -- Role of the Extracellular Matrix Enzyme Activities and Metastasis -- The Role of Non-Cancerous Cells in Cancer: Pancreatic Ductal Adenocarcinoma as Model to Understand the Impact of Tumor Microenvironment on Epithelial Carcinogenesis -- Heterogeneity of Cancers and its Implication for Targeted Drug Delivery -- A Study of Cancer Heterogeneity: From Genetic Instability to Epigenetic Diversity in Colorectal Cancer -- Nanotherapeutics in Multidrug Resistance -- Stem Cells and Cancer -- Mechanisms of Metastasis -- Cancer-Specific Ligand/Receptor Interactions -- Targeting Drugs to Cancer: A Tough Journey to the Tumor Cell -- Long Circulation and Tumor Accumulation -- Convective and Diffusive Transport in Drug Delivery -- Intravital Real-Time Confocal Laser Scanning Microscopy for the in Situ Evaluation of Nanocarriers -- The EPR effect in Cancer Therapy -- In Vitro 3-dimensional Cancer Culture Model -- Complex Transport Around Tumor: Need for Realistic In Vitro Tumor Transport Model -- The Missing Components Today and the New Treatments Tomorrow.
  • In the western world, the risk of cardiovascular disease in pregnancy has grown due to the increasing age at the first pregnancy and the worldwide obesity epidemic leading to early diabetes and hypertension. As a result more women are requiring drug therapy during pregnancy and some data has shown an altered pharmacodynamic profile in pregnant women when compared to the non-pregnant population. Cardiac Drugs in Pregnancy presents up-to-date research for the treatment of cardiovascular disease during pregnancy, and discusses the most important indications of drug usage in pregnancy and postpartum. The book aims to assess the potential risk of drugs and their possible benefit against each other, making it an essential read for a wide range of health professionals involved in cardiac drug therapy in pregnancy.
  • An effective CMC regulatory compliance strategy for biologics and biopharmaceuticals can seem like a mystery. Through means of this 2nd edition, this no longer needs to occur. A great deal of thanks goes to two regulatory authorities - the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA), who provide through their respective websites, an abundance of guidance, especially in the last several years. So much has changed since the 1st edition of this book was published in 2004. There are now additional manufacturing processes for producing commercial biopharmaceuticals - transgenic plant cell cultures and transgenic animals. In addition to commercial recombinant proteins and monoclonal antibodies, there are now commercial cell-based medicines (cellular therapy) and DNA-based medicines (gene therapy). Biosimilars are now on the marketplace in Europe, and under review for commercial approval in the USA. Vaccine manufacturing has resurged due to the concerns of potentially pandemic mutated animal influenzas (e.g., swine flu, bird flu). Strategic international regulatory guidances have been adopted that are driving the entire pharmaceutical industry, including biopharmaceuticals, to a higher standard of performance, including Quality by Design (QbD), Quality Risk Management (QRM) and Pharmaceutical Quality Systems (PQS). The vast majority of the over 600 regulatory references listed in this book were either issued or updated since the release of the 1st edition. All of these changes are the reason this updated edition includes not only biopharmaceuticals but also other biologics (e.g., live virus vaccines, human plasma-derived proteins, cell-based medicines, natural-sourced proteins) that have CMC regulatory compliance concerns and challenges in common with the genetically-engineered biologics (i.e., the biopharmaceuticals).
  • Inflammatory mechanisms in Alzheimer's disease and other neurodegenerative disorders / Joseph Rogers ... [et al.] -- Treatment development strategies for Alzheimer's disease / Ernst Wulfert -- Lipoprotein-associated phospholipase A as a new prognostic factor for coronary artery disease / Alexandros D. Tselepis -- New molecular targets for the prevention and treatment of gastrointestinal ulcers and inflammation / Sandor Szabo ... [et al.] -- Stress activates corticotropin releasing : factor signaling pathways : implication in functional bowel disorders / Yvette Tache -- Design, synthesis, and pharmacological evaluation of high-affinity and selectivity sigma-1 and sigma-2 receptor ligands / Jacques H. Poupaert -- Synthesis of biologically active taxoids / K.C. Nicolaou and R.K. Guy -- From the molecular pharmacology to the medicinal chemistry of cannabinoids / Didier M. Lambert -- An appraisal of fomocaines : current situation and outlook / Herbert Oelschlager and Andreas Seeling -- Ligands for the GABA recognition site at the GABAA receptor : structure-activity studies / Bente Frlund ... [et al.] -- Strategies for development of new lead structures for inhibition of acetylcholinesterase / Petra Kapkova ... [et al.] -- Discovery of potent and selective inhibitors of human aldosterone synthase (CYP11B2) : a new target for the treatment of congestive heart failure and myocardial fibrosis--a review / R.W. Hartmann ... [et al.] -- Thiocarboxanilides : a new class of nonnucleoside reverse transcriptase inhibitors (NNRTIs) with great potential for the treatment of human immunodeficiency virus type 1 (HIV-1) infections / E. De Clercq, A. Karlsson, and J. Balzarini -- Histamine H-receptor agonists and antagonists : chemical, pharmacological, and clinical aspects / Holger Stark and Walter Schunack -- Anti-inflammatory actions of flavonoids and structural requirements for new design / Theoharis C. Theoharides -- Molecular mechanisms of HO-induced DNA damage : the action of desferrioxamine / M. Tenopoulou, P.-T Doulias, and D. Galaris -- LNA (locked nucleic acid) and functionalized LNA : towards efficient gene targeting / Jesper Wengel -- The effect of diet on drug metabolism / K.J. Netter -- Cytochromes P450 in the metabolism and bioactivation of chemicals / Costas Ioannides -- In vitro methods to measure drug metabolism and drug interactions in drug discovery and development / O. Pelkonen ... [et al.] -- How to probe the sites of action of drug molecules / A. Makriyannis and F. Bitter -- Physicochemical profiling in early drug discovery : new challenges at the age of high-throughput screen and combinatorial chemistry / Bernard Faller -- Drug membrane interaction and its importance for drug efficacy / J.K. Seydel ... [et al.] -- The fight against AIDS : new avenues for inhibiting reverse transcriptase (RT), and old target / Maurizio Botta ... [et al.].
  • Part 1. Synthesis and characterization of chitin and chitosan derivatives -- part 2. Biological activities of chitin and chitosan derivatives -- part 3. Biomedical applications of chitin and chitosan derivatives.
  • Introduction : the practice of clinical pharmacy -- Communication skills for the pharmacist -- Taking medication histories -- Physical assessment skills -- Review of laboratory and diagnostic tests -- The patient case presentation -- Therapeutics planning -- Monitoring drug therapies -- Researching and providing drug information -- Ethics in pharmacy and health care.
  • Overview of combination products -- Ensuring successful combination product development -- Overview of FDA and other regulatory agency expectations -- Resource requirements -- Manufacturing of combination products -- Challenges and pitfalls to avoid with combination products -- Postlaunch compliance requirements -- Agency audits and challenges.
  • Respiratory system -- Ophthalmology -- Ear conditions -- Central nervous system -- Women's health -- Gastroenterology -- Dermatology -- Musculoskeletal conditions -- Paediatrics -- Specific product requests.
  • A short history of controlled drug release -- The organization of the gut and oral absorption of drugs: anatomical, biological and physiological considerations in oral formulation development -- Controlling drug release in oral product development programs: an industrial perspective -- Animal model systems suitable for controlled release modeling -- In Vitro testing of controlled release dosage forms during development and manufacture -- Oral controlled delivery mechanisms and technologies -- Drug-polymer matrices for extended release -- Ion-exchange approaches to controlling drug release -- Pulsatile delivery for controlling drug release -- Ordered mesoporous silica for the delivery of poorly soluble drugs -- Geometric release systems: principles, release mechanisms, kinetics, polymer science, and release-modifying material -- Extrudable technologies for controlling drug release -- Coated multiparticles for controlling drug release -- Capsules as a delivery system for modified-release products -- Lipids in oral controlled release drug delivery -- Biccal drug delivery -- Controlling release by gastroretention -- Drug delivery to the colon.
  • Introduction / Wayne R. Gombotz and Steven J. Shire -- Design of therapeutic MABS. CDR repair: a novel approach to antibody humanization / Mark S. Dennis -- Nanobodies, single-domain antigen-binding fragments of camelid heavy-chain antibodies / Gholamreza Hassanzadeh Ghassabeh, Serge Muyldermans, and Dirk Saerens -- Expression and production of MABS. GPEx® a flexible method for the rapid generation of stable, high expressing, antibody producing mammalian cells lines / Gregory T. Bleck -- Advancing our cell culture platform: incorporating lessons learned and new technologies / Carole Heath -- Recovery and purification. Addressing changes associated with technology transfer: a case study / Michele M. Myers ... [et al.] -- Concepts for disposables in biopharmaceutical manufacture / Joachim K. Walter and Uwe Gottschalk -- Formulation and delivery. Formulation and delivery issues for monoclonal antibody therapeutics / Ann L. Daugherty and Randall J. Mrsny -- Challenges in the development of high protein concentration formulations / Steven J. Shire, Zahra Shahrock, and Jun Liu -- Protein immobilization by crystallization and precipitation: an alternative to lyophilization / Karoline Bechtold-Peters -- Analytics and specification setting for MABS. Characterizing high affinity antigen/antibody complexes by kinetic and equilibrium based methods / Andrew W. Drake, David G. Myszka, and Scott L. Klakamp -- Analytical characterization of monoclonal antibodies: linking structure to function / Reed J. Harris ... [et al.] -- Analysis of irreversible aggregation, reversible self-association and fragmentation of monoclonal antibodies by analytical ultracentrifugation / James D. Andya, Jun Liu, and Steven J. Shires -- Biophysical signatures of monoconal antibodies / N. Harn ... [et al.] -- Pharmacokinetics and immunogenicity. Impact of Fc glycosylation on monoclonal antibody effector functions and degradation by proteases / T. Shantha Raju -- Immunogenicity assessment of antibody therapeutics / P. stas, Y. Gansemans, and I. Lasters -- Armed antibodies and new classes of antibodies. Production of monoclonal antibodies in E. coli / Dorothea E. Reilly and Daniel G. Yansura -- Recent advances in the use of antibody drug conjugates for cancer theapy / Peter D. Senter -- Antibody radiolabeling / Corinne Bensimon and Russell Redshaw.
  • Antidepressant compounds : a critical review / S.W. Tang, D.M. Helmeste, B. Leonard -- The hypothalamic-pituitary-adrenal axis in depression / M. Julio-Pieper, T.G. Dinan -- Dysfunctional circadian rhythms and mood disorders : opportunities for novel therapeutic approaches / T.R. Norman -- The concept of depression as a dysfunction of the immune system / B.E. Leonard -- The role of polyunsaturated fatty acids in the pathology and treatment of depression / C. Song -- Overcoming antidepressant treatment resistance : focus on glutamate / J.W. Murrough, S.J. Mathew -- Neuroimaging and the pathophysiology and treatment of depression : recent advances and future needs / D.M. Cannon -- Animal models of depression : where are we going? / D.A. Slattery, J.F. Cryan -- Genetic models of depression and antidepressant response / I. Lucki -- The role of 5-HT2C receptors in the antidepressant response : a critical review / C.B.P. Martin ... [et al.] -- Chromatin-based treatments for affective disorders : insight or utopia / H.E. Covington III, O. Berton -- Neurotrophic factors and antidepressant action : recent advances / O.F. O'Leary, E. Castron -- Neurogenic basis of antidepressant action : recent advances / A. Tanti, C. Belzung -- The nature and treatment of therapy-resistant depression / S.H. Kennedy, S.J. Rizvi, P. Giacobbe -- Optimizing antidepressant management of depression : current status and future perspectives / T.L. Schwartz, S.M. Stahl.
  • This dictionary details various terms typically used in pharmaceutical medicine. It also explains commonly used abbreviations.
  • This authoritative volume provides a contemporary view on the latest research in molecules with optimal drug-like properties. It is a valuable source to access current best practices as well as new research techniques and strategies. Written by leading scientists in their fields, the text consists of fourteen chapters with an underlying theme of early collaborative opportunities between pharmaceutical and discovery sciences. The book explores the practical realities of performing physical pharmaceutical and biopharmaceutical research in the context of drug discovery with short timelines and low compound availability. Chapters cover strategies and tactics to enable discovery as well as predictive approaches to establish, understand and communicate risks in early development. It also examines the detection, characterization and assessment of risks on the solid state properties of advanced discovery and early development candidates, highlighting the link between solid state properties and critical development parameters such as solubility and stability. Final chapters center on techniques to improve molecular solubilization and prevent precipitation, with particularly emphasis on linking physiochemical properties of molecules to formulation selection in preclinical and clinical settings.
  • "Discussion Framework for Clinical Trial Data Sharing: Guiding Principles, Elements, and Activities is part of a study of how data from clinical trials might best be shared. This document is designed as a framework for discussion and public comment. This framework is being released to stimulate reactions and comments from stakeholders and the public. The framework summarizes the committee's initial thoughts on guiding principles that underpin responsible sharing of clinical trial data, defines key elements of clinical trial data and data sharing, and describes a selected set of clinical trial data sharing activities."--Publisher's website.
  • This book describes the different approaches for drug delivery to the brain with an emphasis on the physiology of the blood-brain barrier (BBB) and the governing principles and concepts for drug delivery across the BBB. It contains cutting-edge methods for studying drug delivery and administering drugs into the brain. The book also explores different approaches for predicting human brain concentrations as well as the influence of disease and drug industry perspectives. In addition to wide-ranging coverage of physiological concepts relevant to central nervous system (CNS) drug delivery, a detailed review of brain structure, function, blood supply and fluids is also provided. In each chapter, descriptions of future challenges and unresolved questions are combined with points for discussion. This unique combination of material makes this book a valuable resource for students and for established academic and industry scientists looking to learn about state-of-the-art drug delivery research. It is also a source for stimulating new ideas among experts already performing CNS drug delivery research or working in related areas. Margareta Hammarlund-Udenaes (Ph.D.) is a Professor in Pharmacokinetics and Pharmacodynamics (PK/PD) at Uppsala University and the Head of the Translational PK/PD Group. Her research is focused on studying pharmacokinetic aspects of BBB transport of drugs in relation to CNS effects, and it has led to the development of new concepts and methods within the BBB transport area, focusing on unbound drug relationships. Elizabeth C.M. de Lange (Ph.D.) is Head of the Target Site Equilibration Group at the Division of Pharmacology of the Leiden Academic Center for Drug Research (LACDR). Her research program focuses on the development of generally applicable predictive PK/PD models on CNS drugs using advanced in vivo animal models and mathematical modeling techniques, with a number of recent successes. Robert G. Thorne (Ph.D.) is an Assistant Professor in Pharmaceutical Sciences at the University of Wisconsin-Madison School of Pharmacy. He was previously a research scientist and faculty member in the Department of Physiology & Neuroscience at the New York University School of Medicine. His research focuses on diffusive and convective transport within the CNS and the development, refinement and optimization of strategies for delivering biologics into the brain.
  • Unique work on structure-based drug design, covering multiple aspects of drug discovery and development. Fully colored, many images, computer animations of 3D structures (these only in electronic form). Makes the spatial aspects of interacting molecules clear to the reader, covers multiple applications and methods in drug design. Structures by mode of action, no therapeutic areas. Of high relevance for academia and industrial research. Focus on gene technology in drug design, omics-technologies computational methods experimental techniques of structure determinationmultiple examples on mode of action of current drugs, ADME-tox properties in drug development, QSAR methods, combinatorial chemistry, biologicals, ribosome, targeting protein-protein interfaces.
  • Introduction. Drug discovery in the 21st century -- ch. 1. Natural products / Charles B. Spainhour -- ch. 2. Cancer cell proteomics using molecular aptamers / Weihong Tan ... [et al.] -- ch. 3. Molecular similarity methods and QSAR models as tools for virtual screening / Jürgen Bajorath -- ch. 4. Systems biology : applications in drug discovery / Sean Ekins ...[et al.] -- ch. 5. High throughput flow cytometry / Larry A. Sklar ... [et al.] -- ch. 6. Combining NMR spectral information with associated structural features to form computationally nonintensive, rugged, and objective models of biological activity / Richard D. Beger, Dan A. Buzatu, and Jon G. Wilkes -- ch. 7. Using Microsoft Excel as a laboratory data management tool / A. Erik Rubin, Mark F. Russo, and William Neil -- ch. 8. Age of regulation / Sandy Weinberg and Gerald J. Whartenby -- ch. 9. Simultaneous screening of multiple cell lines using the CellCard system / Oren E. Beske -- ch. 10. Protein X-ray crystallography in drug discovery / Peter Nollert ... [et al.] -- ch. 11. Biological and chemistry assays available during drug discovery and developability assessment / Duane B. Lakings -- ch. 12. Strategies and methods in monitoring and targeting protein-protein interactions / Arianna Loregian and Giorgio Palù -- ch. 13. High-throughput screening : evolution of technology and methods -- Martyn N. Banks ... [et al.] -- ch. 14. Metal-enhanced fluorescence : application to high-throughput screening and drug discovery / Kadir Aslan ... [et al.] -- ch. 15. Methods for the design and analysis of replicate-experiment studies to establish assay reproducibility and the equivalence of two potency assays / Brian J. Eastwood ... [et al.] -- ch. 16. Coupled luminescent methods in drug discovery : 3-minute assays for cytotoxicity and phosphatase activity / Michael J. Corey and Robert J. Kinders -- ch. 17. Design and pharmaceutical applications of prodrugs / Tomi Järvinen ... [et al.] -- ch. 18. GABA and glutamate receptor ligands and their therapeutic potential in CNS disorders / Ulf Madsen ... [et al.] -- ch. 19. Cardiac sarcolemmal ATP-sensitive potassium channel antagonists : novel ischemia-selective antiarrhythmic agents / George E. Billman -- ch. 20. Factors influencing the efficacy of mediator-specific anti-inflammatory, glucocorticoid, and anticoagulant therapies for sepsis / Peter C. Minneci ... [et al.] -- ch. 21. Combinatorial chemistry in the drug discovery process / Nathan T. Ross, Brian R. McNaughton, and Benjamin L. Miller -- ch. 22. Herbal medicines and animal models of gastrointestinal diseases / C.H. Cho and J.K.S. Ko -- ch. 23. Endocrine and metabolic agents / Brian L. Furman -- ch. 24. Respiratory viruses / Paul D. Olivo -- ch. 25. Strategies in the design of antiviral drugs / Erik De Clercq and Piet Herdewijn -- ch. 26. Protein kinase inhibitors in drug discovery / Keykavous Parang and Gongqin Sun -- ch. 27. RNA-based therapies / Steve Pascolo -- ch. 28. Novel imaging agents for molecular MR imaging of cancer / Dmitri Artemov and Zaver M. Bhujwalla -- ch. 29. Targets and approaches for cancer drug discovery / Susan L. Mooberry.
  • Introduction to Drug-Drug Interactions -- Mechanisms of Drug Interactions I: Absorption, Metabolism, and Excretion -- Mechanisms of Drug Interactions II: Transport Proteins -- Drug-Food Interactions -- Interactions Between Herbs and Antiinfective Medications -- Drug-Cytokine Interactions -- Beta-Lactam Antibiotics -- Macrolides, Azalides, and Ketolides -- Quinolones -- Glycopeptides, Lipopeptides, and Lipoglycopeptides -- Miscellaneous Antibiotics -- Drugs for Tuberculosis -- Drug Interactions with Antiretrovirals for HIV Infection -- Non-HIV Antiviral Agents -- Antifungal Agents -- Antimalarial Agents -- Antiprotozoal and Anthelmintic Agents -- Drug Interaction Considerations Throughout Drug Development -- Probe Cocktail Studies -- Design and Data Analysis in Drug Interaction Studies.
  • 1. Pharmacokinetics -- 2. Drug Metabolizing Enzymes -- 3. Oral Absorption -- 4. Transporters -- 5. Metabolism-Based Drug Interactions -- 6. Biotransformation and Bioactivation -- 7. Prediction of Human Pharmacokinetics -- 8. Advances in Bioanalysis as It Relates to ADME -- 9. ADME Properties and Their Dependence on Physicochemical Properties -- 10. In Silico ADME Tools -- 11. Approved Drugs -- 12. Chemical Nomenclature.
  • Easy injections 2007
    Introduction to injections -- Medications and injection supplies -- Joints -- Tendons -- Bursae -- Nerves -- Trigger point injections -- Botulinum toxin -- Prolotherapy -- Acupuncture -- Sympathetic injections -- Spinal injections.
  • "This book introduces readers to structured systems analysis and the medications domains. It starts off with top-down decomposition of workflows and data. It applies structured systems analysis methodology and tools to electronic prescription, computerized physician order entry, drug dispensation, medication administration, and clinical decision support. Providing a comprehensive view of the EHR/EMR, the text covers user interface considerations, reporting requirements, and standards and vocabularies for meaningful use. Assuming no previous clinical and/or informatics knowledge, the author uses accessible language and includes over 250 figures and 100 review questions with answers"--Provided by publisher.
  • Pharmakokinetics -- Pharmacodynamics and signal transduction -- Toxicology -- Treatment of infectious diseases -- Cancer and immunopharmacology -- Autonomic nervous system -- Hematology -- Cardiovascular system -- Renal system -- Inflammatory disorders -- Gastrointestinal pharmacology -- Endocrine pharmacology -- Central nervous system.
  • Enhancing Medication Adherence: The Public Health Dilemma is a comprehensive guide to medication adherence for the healthcare professional. Clinicians and pharmacists alike can benefit from key opinion leader and author Hayden Bosworth's text as he explains the details and causes behind medication nonadherence as well as methods on how healthcare providers can determine if a patient is nonadherent. Additionally, Bosworth discusses various studies, which assess adherence, adherence-related technology, best practices for clinicians and pharmacists, and future directions and recommendations in the field.
  • Introduction to the guidelines. Purpose, target and scope -- Background -- A dual obligation, a quadruple imperative -- Indispensability of controlled medicines in contemporary medical practices -- Safety of controlled medicines -- Current availability -- Impediments to availability, accessibility and affordability -- Why and how to work with this document? -- Guidelines for ensuring balance in national policies on controlled substances. Content of drug control legislation and policy -- Authorities and their role in the system -- Policy planning for availability and accessibility -- Healthcare professionals -- Estimates and statistics -- Procurement -- Other -- Country assessment checklist.
  • "There has been explosive growth in the hunt for new pharmaceutically agents globally. Traditionally, this has been the purview of the pharmaceutical industry, but today, this effort crosses academic, government, and industry laboratories across the world. Enzymes remain the most valued and common of drug targets; hence, a detailed understanding of their interactions with inhibitors is critical to successful drug discovery. This book provides a practical, readable, and comprehensive treatment of these topics that allows scientists to master the art of applied enzymology for drug discovery. The book addresses the opportunities for inhibitor interactions with enzyme targets arising from consideration of the catalytic reaction mechanism; discusses how inhibitors are properly evaluated for potency, selectivity, and mode of action, covers the potential advantages and liabilities of specific inhibition modalities with respect to efficacy in vivo, and provides valuable biochemical insights to help medicinal chemists and pharmacologists most effectively pursue lead optimization. It includes two new chapters, one on the pioneering idea of drug-target residence time fostered by Dr. Copeland, and the second on quantitative biochemistry. Five new appendices are added"--Provided by publisher.
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    "This publication provides readers with a thorough understanding of enzyme-inhibitor evaluation to assist them in their efforts to discover and optimize novel drug therapies. Key topics such as competitive, noncompetitive, and uncompetitive inhibition, slow binding, tight binding, and the use of Hill coefficients to study reaction stoichiometry are all presented. Examples of key concepts are presented with an emphasis on clinical relevance and practical applications."--Jacket.
  • FDA for doctors 2014
    "This book explains the Food and Drug Administration (FDA) as an institution and provides understanding of its nomenclature, societal role, policies, goals and challenges. While many readers will have some knowledge of the FDA, few have an appreciation of the many specific areas of FDA authority. The FDA for Doctors is not for those looking for detailed instruction on dealing with the FDA or its operations. Rather, it is written by a doctor with doctors in mind, with the hope that the information in this book will make physicians, and other readers, more thoughtful and insightful, especially with regards totherapeutics and the many broad societal issues underlying FDA's activities. With over 40 years of experience as a clinical investigator in many trials done for FDA registration, the author has been a member of and chaired an FDA advisory committee, and has been a consultant to several divisions of the FDA. He has also had the opportunity to serve on the U.S. Senate Labor Committee, helping with its FDA oversight activities. In addition to a long academic medical career the author has been a consultant to and a full time employee of drug and device companies"--Back cover.
  • 1. Route-Specific Challenges in the Delivery of Poorly Water-Soluble Drugs / Stephanie Bosselmann and Robert O. Williams III -- 2. Optimizing the Formulation of Poorly Water-Soluble Drugs / Kevin P. O'Donnell and Robert O. Williams III -- 3. Solid-State Techniques for Improving Solubility / Justin R. Hughey and Robert O. Williams III -- 4. Mechanical Particle-Size Reduction Techniques / Javier O. Morales, Alan B. Watts, and Jason T. McConville -- 5. Solubilized Formulations / Feng Zhang and James C. DiNunzio -- 6. Injectable Formulations of Poorly Water-Soluble Drugs / Michael P. Boquet and Dawn R. Wagner -- 7. Design and Development of Self-Emulsifying Lipid Formulations for Improving Oral Bioavailability of Poorly Water-Soluble and Lipophilic Drugs / Ping Gao -- 8. Structured Development Approach for Amorphous Systems / Navnit Shah, Harpreet Sandhu, Duk Soon Choi, Oskar Kalb, Susanne Page, and Nicole Wyttenbach -- 9. Melt Extrusion / James C. DiNunzio, Feng Zhang, Charlie Martin, and James W. McGinity -- 10. Spray-Drying Technology / Dave A. Miller and Marco Gil -- 11. Pharmaceutical Cryogenic Technologies / Wei Yang, Donald E. Owens III, and Robert O. Williams III -- 12. Precipitation Technologies for Nanoparticle Production / Jasmine M. Rowe and Keith P. Johnston -- 13. Emerging Technologies to Increase the Bioavailability of Poorly Water-Soluble Drugs / Justin R. Hughey and James W. McGinity -- 14. Scientific and Regulatory Considerations for Development and Commercialization of Poorly Water-Soluble Drugs / Zedong Dong and Hasmukh Patel.
  • High-throughput gene cloning using the Gateway technology / Scott N. Peterson ... [et al.] -- Protein expression for microarrays / Harry H. Yim, Thomas G. Chappell, and Steven H. Harwood -- Emerging trend: cell-free protein expression / Federico Katzen and Wieslaw Kudlicki -- The critical role of surface chemistry in protein microarrays / Athena Guo and X.-Y. Zhu -- Fabrication of sol-gel-derived protein microarrays for diagnostics and screening / Nicholas Rupcich and John D. Brennan -- Printing and QC of functional protein microarrays / Dee Shen, Fang X. Zhou, and Barry Schweitzer -- Protein engineering for surface attachment / Aparna Girish, Grace Y. J. Chen, and Shao Q. Yao -- Protein in situ arrays through cell-free protein synthesis / Mingyue He ... [et al.] -- Fluorescent detection methods for protein microarrays / Steven Roman and Scott Clarke -- Functional analysis of protein interactions using surface plasmon resonance-based microarrays / Alan McWhirter and Stefan Löfås -- Leaving the surface behind: at the intersection of protein microarrays and mass spectrometry / Darrell P. Chandler ... [et al.] -- High-resolution label-free detection applied to protein microarray research / Lance G. Laing and Brian Cunningham -- Studying protein-protein interactions with protein microarrays: rapid identification of 14-3-3 protein binding partners / Jun-ichi Satoh -- A combined force of chemical genetics and protein microarrays / Heng Zhu and Jing Huang -- Antibody profiling for protein drug development and clinical development / Steve H. Herrmann -- Humoral response profiling using protein microarrays / Arun Sreekumar ... [et al.] -- DNA interactions with arrayed proteins / Marina Snapyan and Vehary Sakanyan -- G protein-coupled receptor microarrays for drug discovery / John Salon ... [et al.] -- Kinase substrate identification using yeast protein microarrays / Geeta Devgan and Michael Snyder -- Protein microarray image analysis / Minzi Ruan -- The analysis of protein arrays / Brad Love -- Evaluating precision and recall in functional protein arrays / Keith Robison -- Visualization of protein microarray data / Kevin Clancy.
  • Fundamental Implications for Clinical Practice -- Translational Effectiveness in the Context of Translational Science -- Comparative Effectiveness Analysis and Evidence-Based Decisions -- Methodology I: The Best Available Evidence -- Methodology II: Sampling and Assessment of the Evidence -- Methodology III: Systematic Evaluation of the Statistical Analysis: Data Analysis in Research Synthesis -- Optimizing Clinical Practice-Based Patient-Centered Outcomes Research -- Getting and Understanding Data -- Obtaining Data -- Describing and Analyzing Data -- Translational Effectiveness Analysis -- Optimizing Clinical Outcomes by Individualizing Observations -- Evaluation in Patient-Centered Outcomes Research -- Translational Effectiveness in Practice-Based Patient-Centered Outcomes Research.
  • Established as a classic text on nuclear chemistry and pharmacy, 'Fundamentals of Nuclear Pharmacy' has been thoroughly revised and now includes new information covering innovations in imaging technology and clinical applications in the field.
  • Nanoscience and nanotechnology overview -- Liposome preparation and characterization -- Solid polymeric nanoparticles -- Lipid nanoparticles -- Polymeric vesicles -- Low molecular weight amphiphile micelles -- Polymeric micelles -- Niosomes -- Quantum dots -- Magnetic particles -- Drug nanoparticles -- Polymeric pro-drugs -- Therapeutic Applications of pharmaceutical nanosystems -- Drug solubilisation -- Gene therapy -- Chemotherapy -- Tissue engineering -- Anti-infectives -- Vaccination -- Anti-arthritic drugs -- Imaging agents -- Commercial exploitation of pharmaceutical nanosystems -- Future perspectives -- Multiple Choice -- Problem Sets -- Case Studies -- Suggested Reading.
  • A perspective on the future clinical impact of genetic diagnosis and gene-based drug therapies for patient health / Julian W. Tang -- Virally-encoded microRNA (miRNA): candidates for gene silencing / Ralph A. Tripp ... [et al.] -- Development of gene profile-responsive antisense agents / Sergei A. Kazakov and Brian H. Johnston -- Gene profiles in drug development: applications in target identification, biomarker discovery, and compound characterization / Eric A.G. Blomme and Dimitri Semizarov -- Gene profiles and cancer / Beverly A. Teicher -- RNA viruses and RNA-based drugs: a perfect match for RNA delivery and the identification of candidate therapeutic target inflammatory molecules / Brett A. Lidbury ... [et al.] -- Ethical considerations for a genetic future in diagnosis and drug development / Lexie Brans and Brett A. Lidbury.
  • "This book collects in-depth discussions from more than 30 noted specialists on topics such as quality control, experimental formulations, pharmaceutical ingredients, conventional and modified-release products, and bioequivalence. It considers key elements in the formulation of generic drug products including the availability of raw materials and chemical purity. It contains new chapters on experimental formulation development, and the relationship between the FDA and the United States Pharmacopeia"--Provided by publisher.
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    Generic drugs are now familiar objects in clinics, drugstores, and households around the world. We like to think of these tablets, capsules, patches, and ointments as interchangeable with their brand-name counterparts: why pay more for the same? And yet they are not quite the same. They differ in price, in place of origin, in color, shape, and size, in the dyes, binders, fillers, and coatings used, and in a host of other ways. Claims of generic equivalence, as physician-historian Jeremy Greene reveals, are never based on being identical to the original drug in all respects, but in being the same in all ways that matter. How do we know what parts of a pill really matter? Decisions about which differences are significant and which are trivial in the world of therapeutics are not resolved by simple chemical or biological assays alone. Questions of therapeutic similarity and difference are also always questions of pharmacology and physiology, of economics and politics, of morality and belief. Greene chronicles the social, political, and cultural history of generic drugs, narrating the evolution of the generic drug industry from a set of mid-twentieth-century "schlock houses" and "counterfeiters" into an agile and surprisingly powerful set of multinational corporations in the early twenty-first century. The substitution of bioequivalent generic drugs for more expensive brand-name products is a rare success story in a field of failed attempts to deliver equivalent value in health care for a lower price. Greene's history sheds light on the controversies shadowing the success of generics: problems with the generalizability of medical knowledge, the fragile role of science in public policy, and the increasing role of industry, marketing, and consumer logics in late-twentieth-century and early twenty-first century health care.
  • Genomic Biomarkers for Pharmaceutical Development: Advancing Personalized Health Care provides an in-depth review of the state of translational science across all stages of pharmaceutical development with a special focus on personalized health care. This book provides a complete picture of biomarker development and validation in a pharmaceutical setting while addressing the inherent challenges of targeting the appropriate indications, biomarker robustness, regulatory hurdles, commercialization and much more. It features case studies devoted to the applications of pharmacogenomics, toxicogenomics, and other genetic technologies as they support drug discovery and development. With chapters written by international authorities in industry and academia, this work is a truly unique presentation of the thoughts and approaches that lead to the development of personalized medicine. Intended for all those involved in clinical translational research, this book is the ideal resource for scientists searching for the applications, strategies and successful approaches of translational science in pharmaceutical development. Provides case studies in applications of pharmacodynamic and predictive markers in drug development in oncology, autoimmunity, respiratory diseases and infectious diseases. Shows how to identify potential new therapeutic targets in different diseases and provides examples of potential new disease indications for life cycle management of drugs. Authored by leading international experts from industry and academia.
  • Particulate systems: manufacture and characterization -- Sampling and measurement biases -- Particle size descriptors and statistics -- Behavior of particles -- Instrumental analysis -- Methods of particle size measurement and their importance for specific applications (instrument synergy) -- Particle size behavior and physical behavior of a powder -- Clinical effect of pharmaceutical particulate systems.
  • There are many steps on the road from discovery of an anticancer drug to securing its final approval by the Food and Drug Administration. In this thoroughly updated and expanded second edition of the Handbook of Anticancer Pharmacokinetics and Pharmacodynamics, leading investigators synthesize an invaluable overview of the experimental and clinical processes of anticancer drug development, creating a single indispensable reference that covers all the steps from the identification of cancer-specific molecular targets to screening techniques and the development and validation of bioanalytical methods to clinical trial design and all phases of clinical trials. The authors have included new material on phase 0 trials in oncology, organ dysfunction trials, drug formulations and their impact on anticancer drug PK/PD including strategies to improve drug delivery, pharmacogenomics and cancer therapy, high throughput platforms in drug metabolism and transport pharmacogenetics, imaging in drug development and nanotechnology in cancer. Authoritative and up-to-date, Handbook of Anticancer Pharmacokinetics and Pharmacodynamics, 2nd Edition provides in one comprehensive and highly practical volume a detailed step-by-step guide to the successful design and approval of anticancer drugs. Road map to anticancer drug development from discovery to NDA submission Discussion of molecular targets and preclinical screening Development and validation of bioanalytical methods Chapters on clinical trial design and phase 0, I, II, III clinical trials Pharmacokinetics, pharmacodynamics, pharmacogenomics, and pharmacogenetics of anticancer agents Review of the drug development process from both laboratory and clinical perspectives New technological advances in imaging, high throughput platforms, and nanotechnology in anticancer drug development.
  • With just over half a decade passing since the first edition of the Handbook of Pediatric Cardiovascular Drugs was published, it remains the only book of its nature to provide health care practitioners with a tool to safely and consistently prescribe and administer cardiovascular drugs in children with cardiac disease. In this new edition, the editors have updated this important resource in collaboration with highly reputed authors. This pocket reference handbook remains tailored to help cardiovascular practitioners meet the daily challenges of caring forpatients, from the newborn to the young adult, with cardiac disease. In addition to providing an extensive review of all cardiovascular medications, the Handbook of Pediatric Cardiovascular Drugs, 2nd Edition also discusses the information required to assist caregivers in their daily clinical practice. Physicians, fellows, residents, nurse practitioners, physician assistants, pharmacists, nurses and other practitioners alike will find this handbook to be an essential resource for drug therapy in complex and high-risk patients with acquired and congenital heart disease.
  • This book compiles multidisciplinary efforts to conceptualize the environment in research and clinical setting that creates the fertile ground for the practical utility of personalized medicine decisions and also enables clinical pharmacogenomics for establishing pharmacotyping in drug prescription. Its covers innovative drug formulations and nanotheranostics, molecular imaging and signatures, translational nanomedicine and informatics, stem cell therapy approaches, modeling and predictability of drug response, pharmacogenetics-guided drug prescription, pediatric drug dosing, pharmacovigila.
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  • Evidence based herbal drugs are on hi-acceptance day by day due to health friendly nature compared to synthetic drugs. The active ingredients in herbal drugs are different chemical classes, e.g. alkaloids, coumarins, flavonoids, glycosides, phenols, steroids, terpenes etc., are identified at molecular level using current analytical practices, which are unique characteristic, as finger, so known as fingerprints. The fingerprints are used for assessment of quality consistency and stability by visible observation and comparison of the standardized fingerprint pattern, have scientific potential to decipher the claims made on these drugs for authenticity and reliability of chemical constituents, with total traceability, which starts from the proper identification, season and area of collection, storage, their processing, stability during processing, and rationalizing the combinational in case of polyherbal drugs. These quality oriented documents have ample scientific logics so well accepted globally by regulatory authorities and industries, to determine intentional/ unintentional contamination, adulteration, pollutants, stability, quality, etc. parameters. Based on geo-climatic factors, a same plant species has different pharmacological properties due to different ingredients; such regional and morphological variations are identified by fingerprints, at the time of collection of the medicinal herb. The chromatographic (TLC, HPTLC, HPLC, GC,) and spectral (UV-Vis., FTIR, MNR, MS, LC-MS, GC-MS etc.) techniques have world-wide strong scientific approval as validated methods to generate the fingerprints of different chemical classes of active ingredients of herbal drugs. Presently there is a need for a book having all the fingerprinting techniques for herbal drugs at a place with theory, case studies and art to discover patentable forms. The present book is a mile stone in the subject, to be utilized by Scientists, Medical Doctors, Technicians, Industrialists, Researchers, and Students both in PG and UG levels.
  • High throughput sample preparation techniques and their application to bioanalytical protocols and purification of combinatorial libraries / Krishna Kallury -- High-throughput quantitative bioanalysis / Katty X. Wan -- Optimizing LCMS equipment to increase throughput in pharmaceutical analysis / Michael G. Frank and Douglas E. Mcintyre -- Throughput improvement of bioanalytical LC-MS/MS by sharing of detector between HPLC systems / Min Shuan Chang and Tawakol El-Shourbagy -- High throughput strategies for metabolite identification in drug discovery / Patrick J. Rudewicz, Qin Yue, and Young Shin -- Utilizing micro parallel liquid chromatography for high-throughput analyses in the pharmaceutical industry / Sergio A. Guazzotti -- Strategies and techniques for higher throughput ADME/PK assays / Walter Korfmacher -- High-throughput analysis in drug metabolism during early drug discovery / Yau Yi Lau -- High-throughput analysis in the support of process chemistry and formulation research & development in the pharmaceutical industry / Zhong Li -- On-line SPE LC/MS/MS for high throughput bioanalytical analysis / Dong Wei and Liyu Yang -- Applications of high-throughput analysis in therapeutic drug monitoring / Quanyun A. Xu and Timothy L. Madden -- High-throughput quantitative pharmaceutical analysis in drug metabolism and pharmacokinetics (DMPK) using liquid crhomatrography-mass spectrometry / Xiaohui Xu -- Designing high throughput HPLC assays for small and biological molecules / Roger K. Gilpin and Wanlong Zhou -- The advances in capillary and nano-HPLC technology for drug discovery and development / Frank J. Yang and Richard Yu -- High-throughput analysis of complex protein mixtures by mass spectrometry / Kojo S.J. Elenitoba-Johnson.
  • Application of parallel synthesis to the optimization of inhibitors of the ZipA-FtsZ protein-protein interaction / Lee D. Jennings -- Case studies of parallel synthesis in hit identification, hit exploration, hit-to-lead, and lead optimization programs / Alexander Ernst and Daniel Obrecht -- A successful application of parallel synthesis to computer-assisted structural optimization of new leads targeting human immunodeficiency virus-1 reverse transcriptase : the case of acylthiocarbamates and thiocarbamates / Angelo Ranise, Andrea Spallarossa, and Sara Cesarini -- How high-throughput medicinal chemistry can expedite lead discovery, lead optimization, and beyond / Rongshi Li -- Rapid lead identification of inhibitors of adenine nucleotide translocase: a case study of applying combinatorial chemistry techniques in drug discovery / Yazhong Pei, Walter H. Moos, and Soumitra Ghosh -- Parallel synthesis of anticancer, antiinflammatory, and antiviral agents derived from L- and D-amino acids / Robert C. Reid and David P. Fairlie -- Application of solid-phase parallel synthesis in lead optimization studies / Bijoy Kundu -- High-throughput solid-phase synthesis of nucleoside-based libraries in the search for new antibiotics / Dianqing Sun and Richard E. Lee.
  • The Good, the bad, and the ugly : a story of two medications -- An Ethical framework -- The Pharmaceutical industry and the free market -- Patents, generic drugs, and academic science -- Research and profits -- Suppression of research data -- The Quality of pharmaceutical research -- The Drug rep: historical background -- The Drug rep today -- The Influence of drug reps: what the data show -- Continuing medical education -- Professional organizations and journal advertising -- The Industry and the consumer -- The FDA: from patent medicines to AIDS drugs -- The FDA and the industry, 1990-2004 -- Solutions: the management and divestment strategies -- Solutions requiring enhanced professionalism in medicine -- Solutions requiring regulatory reform.
  • This detailed volume addresses key issues and subtle nuances involved in developing hydrophilic matrix tablets as an approach to oral controlled release. It brings together information from more than five decades of research and development on hydrophilic matrix tablets and provides perspective on contemporary issues. Twelve comprehensive chapters explore a variety of topics including polymers (hypromellose, natural polysaccharides and polyethylene oxide) and their utilization in hydrophilic matrices, critical interactions impacting tablet performance, in vitro physical and imaging techniques, and microenvironmental pH control and mixed polymer approaches, among others. In one collective volume, Hydrophilic Matrix Tablets for Oral Controlled Release provides a single source of current knowledge, including sections of previously unpublished data. It is an important resource for industrial and academic scientists investigating and developing these oral controlled release formulations.
  • Immunology for pharmacy 2012
    With a new pharmacy-specific approach to immunology, Immunology for Pharmacy prepares pharmacists for practice by providing a complete understanding of the basis of immunology and the consequences of either suppressing or enhancing immune function. It covers key subjects such as prophylaxis and vaccination, antibodies as therapeutic and diagnostic agents, biological modifiers, and the rationale for use and mechanisms of therapeutic agents. Written by experienced author and educator Dennis Flaherty, this book presents topics with a logical, step-by-step approach, explaining concepts and their practical application. A companion Evolve website reinforces your understanding with flashcards and animations. Pharmacy-specific coverage narrows the broad field of immunology to those areas most pertinent and clinically relevant to pharmacy students. 165 full-color illustrations help to illuminate difficult concepts. Factors That Influence the Immune Response chapter covers biological agents including bacteria, viruses, and fungi, and their related toxins and how they relate to the immune system. Three chapters on vaccinations prepare you for this important part of the pharmacist's role by discussing cancer treatment with whole tumor vaccines, cell vaccines, and viral vector vaccines, describing other vaccines such as recombinant vaccines and plant vaccines, and examining how diseases such as diphtheria, whooping cough, and tetanus respond to vaccinations. A summary of drugs used in treating each condition helps you understand typical treatments and their immunological mechanisms, so you can choose proper treatments. Integrated information makes it easier to understand how various parts of the immune system work together, leading to a better understanding of immunology as a whole. A unique focus on practical application and critical thinking shows the interrelationship of concepts and makes it easier to apply theory to practice. Information on AIDS covers the identification and treatment of both strains of HIV as well as AIDS, preparing you for diseases you will see in practice. Unique student-friendly features simplify your study with learning objectives and key terms at the beginning of each chapter, bulleted summaries and self-assessment questions at the end of each chapter, and a glossary at the back of the book. Over 60 tables summarize and provide quick reference to important material. A companion Evolve website includes animations and pharmacy terminology flashcards.
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    This book covers both basic elements and the state-of-the-art in applications of proteomics. The first section gives an introduction to the field, from differential approaches to functional proteomics, including yeast two-hybrid, mass spectrometry, mapping of post-translational modifications, and NMR spectroscopy. The second section offers a complete picture of industry studies in proteomics for human health and biotechnology applications. The final section addresses the future, looking at the most promising areas such as protein arrays and the integration of genomic and proteomic tools.
  • Over the last 30-40 years, information technology (IT) has revolutionized professional life for millions of people around the world. IT has reduced the need for bulk storage of paper records by organizations, has enabled automation of tasks that were previously repetitive and labor-intensive, and carry them out in a fast and accurate way, has enabled economies of scale, improved efficiencies and enabled new ways of working that were hitherto impossible. In parallel with the rise of IT during the last 40 years, the role of the pharmacist - and the society in which pharmacists work - has changed considerably. Pharmacists are no longer principally compounders of medicines, but they are still responsible for ensuring that the patient receives the correct medicine, ensuring that the patient understands why they should take their medicine, and helping the patient with taking the medicine and being concordant with therapy.Information Technology in Pharmacy: an Integrated Approach provides a concise and practical general introduction to pharmacy IT, discusses issues surrounding the adoption of technology and how technologies may be utlilized by the pharmacy profession to exercise new professional roles and achieve new professional aspirations. This book will be of prime interest to practicing pharmacists at all levels, pharmacy students and pharmacy educators, but also to health informaticians, hospital and health care system administrators.
  • V. 1. Acebutolol -- Dapsone -- v. 2. Dauromycin -- Indigotin Disulfonate -- v. 3. Indole-3-Acetic Acid -- Phendimetrazine -- v. 4. Phenelzine -- Zoxazolamine -- v. 5. Raman spectra data -- Mass spectra of pesticides -- Mass spectra of derivatized drugs -- Gas chromatography/infrared spectra of drugs -- v. 6. Standard KBr infrared spectra and standard NMR solvent spectra -- Supplemental infrared spectra -- Supplemental NMR spectra -- Ultraviolet absorption maxima -- Infrared index -- Mass spectra indices of drugs -- Mass spectra indices of pesticides -- Molecular formula index -- Gas chromatographic data -- Index to specific compounds.
  • Introduction to intellectual property -- Obtaining, enforcing and defending patents -- The patent-eligibility of genes -- Medical procedure patents -- Rights and roles of universities and inventors -- Drug development : balancing innovation, access and profits -- Patent battles part I : small-molecule drugs -- Patent battles part II : the Biosimilars Act and biologics -- International patent law, trade law, and access to drugs.
  • Chapter 1. Introduction to enzymes, receptors and the action of small molecule drugs -- chapter 2. Protein structure and function -- chapter 3. The small molecule drug discovery process : from target selection to candidate selection -- chapter 4. Protein therapeutics (introduction to biopharmaceuticals) -- chapter 5. Similarities and differences in the discovery and use of biopharmaceuticals and small-molecule chemotherapeutics -- chapter 6. Therapies for type 2 diabetes : modulating the incretin pathway using small molecule peptidase inhibitors or peptide mimetics -- chapter 7. The structure and business of biopharmaceutical companies including the management of risks and resources -- chapter 8. Discovery and development of the anticancer agent gefitinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase -- chapter 9. Targeting HER2 by monoclonal antibodies for cancer therapy -- chapter 10. Recombinant human erythropoietin and its analogues -- chapter 11. Lysosomal storage disorders : current treatments and future directions -- chapter 12. Hormone replacement therapy -- chapter 13. Design of the anti-HIV protease inhibitor darunavir -- chapter 14. The case of anti-TNF agents -- chapter 15. Discovery of the cholesterol absorption inhibitor, ezetimibe.
  • Part I. Reviews -- 1. An Historical overview of drug discovery / Ana Sofia Pina, Abid Hussain, and Ana Cecília Roque -- 2. Ligand macromolecule interactions : theoretical principles of molecular recognition / Tammy Nolan, Nidhi Singh, and Christopher R. McCurdy -- 3. X-Ray cystallography in drug discovery / Ana Luísa Carvalho, José Trincão, and Maria João Romão -- 4. Virtual screening of compound libraries / Nuno M.F.S.A. Cerqueira, Sérgio F. Sousa, Pedro A. Fernandes, and Maria João Ramos -- Part II: Protocols -- 5. Combinatorial chemistry and the synthesis of compound libraries / Rolf Breinbauer and Matthias Mentel -- 6. Ligand-based nuclear magnetic resonance screening techniques / Aldino Viegas, Anjos L. Macedo, and Eurico Cabrita -- 7. Isothermal titration calorimetry and differential scanning calorimetry / Geoff Holdgate -- 8. Adaptive combinatorial design of focused compound libraries / Gisbert Schneider and Andreas Schüller -- 9. Chemical microarrays : a new tool for discovery enzyme inhibitors / Shuguang Liang, Wei Xu, Kurumi Y. Horiuchi, Yuan Wang, and Haiching Ma -- 10. Fluorescence polarization and time-resolved fluorescence resonance energy transfer techniques for PI3K assays / Kurumi Y. Horiuchi and Haiching Ma -- 11. Small molecule protein interaction profiling with functional protein microarrays / Lihao Meng, Dawn Mattoon, and Paul Predki -- 12. Capillary electrophoresis in drug discovery / Milena Quaglia and Ersilia De Lorenzi -- 13. SPR in drug discovery : searching bioactive compounds in plant extracts / Maria Minunni and Anna Rita Bilia -- 14. Application of frontal affinity chromatography with mass spectrometry (FAC-MS) for stereospecific ligand-macromolecule interaction, detection and screening / Jacek Slon-Usakiewicz and Peter Redden -- 15. GPC spin column HPLC-ESI-MS methods for screening drugs noncovalently bound to proteins / Marshall M. Siegel -- 16. A scintillation proximity assay for fatty acid amide hydrolase compatible with inhibitor screening / Yuren Wang and Philip Jones -- 17. A natural products approach to drug discovery : probing modes of action of antitumor agents by genome-scale cDNA library screening / Hendrik Luesch and Pedro Abreu -- 18. Ligand-macromolecule interactions in live cells by fluorescence correlation spectroscopy / Aladdin Pramanik
  • Liposome technology. 3rd ed. v. 1-3, 2007
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  • Patient Safety and Medication Administration -- Nursing Process Guidelines -- Pharmacologic Classes -- Alphabetical Listing of Drugs by Generic Name.
  • New strategies for traditional medicine -- Developing better herbal medicines in the post-genomic era -- Revitalization of the knowledge of herbs: a way forward to discovery of new drugs -- Ethnobotanical uses of the native flora from Brazilian north-eastern region -- Diversity and uses of the genus croton (euphorbiaceae) in Northeastern Brazil -- Ethnomedical knowledge among the "Quilombolas" from the Amazon region of Brazil with a special focus on plants used as nervous system tonics -- Advances in the knowledge of medicinal plants in Eastern Andalusia, Spain -- Tropical propolis: recent advances in chemical components and Botanical origin -- Anti-malarial plants used in folk medicine in Bangladesh -- Usnea sulcata motyka: an ethnomycological review of its use in traditional medicine -- Sirukurinjan: An ancient remedy for a modern incurable disease, diabetes -- Herbal drugs used for domestic animals -- Endophytes from medicinal plants as novel sources of bioactive compounds -- Advances in medicinal plants with antitumoral activity -- Medicinal plants: how are they used to treat neurological diseases? -- Inflammatory diseases: mechanisms and natural remedies -- Recent advances to evaluate anti-diabetic medicinal plants -- Botanical origin and Biological activity of propolis -- Bioactivity of plant essential oils -- Antibacterial and antiviral effects of aromatic plant-derived essential oils: a scientific and medicinal approach -- Strategies of solvent system selection for the isolation of natural products by countercurrent chromatography.
  • Corticosteroids and related drugs -- Prostaglandins -- Sex hormones and related drugs -- Iodine and drugs that affect thyroid function -- Insulins and other hypoglycemic drugs -- Other hormones and related drugs -- Lipid-regulating drugs -- Endocrine and metabolic adverse effects of non-hormonal and non-metabolic drugs.
  • Elsevier now offers a series of derivative works based on the acclaimed Meyler's Side Effect of Drugs, 15th Edition. These individual volumes are grouped by specialty to benefit the practicing biomedical researcher and/or clinician. Opioids and analgesics are members of a diverse group of drugs used to relieve pain. They are frequently used in combination with prescription and nonprescription pain relievers, and misuse is prevalent. Pain medicine specialists and most physicians or surgeons will find this volume useful in prescribing the appropriate drugs for pain therapy and for preventing mi.
  • Antibacerial Drugs -- Antiviral Drugs, Including Immunoglobulins and Interferons -- Antifungal Drugs -- Antiprotozoal and Antihelminthic Drugs -- Vaccines -- Disinfectants and Antiseptics.
  • Elsevier now offers a series of derivative works based on the acclaimed Meylers Side Effect of Drugs, 15th Edition. These individual volumes are grouped by specialty to benefit the practicing physician or health care clinician. Each year, heart disease kills more people than cancer. Patients are treated by a variety of specialists and primary care practitioners, depending on the organ system involved. This volume enables practitioners to assess the adverse effects of the complete range of drugs used in cardiovascular medicine, including antihypertensive drugs, and drugs used in the treatment.
  • Drugs Used in Cancer Chemotherpy -- Corticosteroids and Prostaglandins -- Cytokines and Cytokine Modulators Interferons -- Monoclonal Antibodies -- Immune Modulators.
  • Antidepressants -- Neuroleptic Drugs -- Hypnosedatives -- Drugs of Abuse -- Drugs use in Alzheimer's Disease -- Psychological and Psychiatric Adverse Effects of Non-Psychoactive Drugs.
  • Antibiotic resistance : postantibiotic era is here / Vladimir Krcmery -- Current challenges in treating methicillin-resistant Staphylococcus aureus : what are the options? / Noha E.I. Sakka & Ian M . Gould -- Antimicrobial-resistant Streptococcus pneumoniae : trends and management / Michael R. Jacobs -- Emergence and management of drug-resistant enterococcal infections / William R. Miller, Barbara E. Murray & Cesar A. Arias -- Enterobacteriaceae that produce newer b-lactamases / Johann D.D. Pitout -- Extensively drug-resistant tuberculosis : new strains, new challenges / Megan Coffee -- Clinical significance of extended-spectrum b-lactamases / Jesés Rodréguez-Baño, Belén Gutiérrez, Lorena Lépez-Cerero & Alvaro Pascual -- Plasmid-mediated quinolone resistance / José Manuel Rodréguez-Marténez, Maréa Eliecer Cano, Jorge Calvo, Álvaro Pascual & Luis Marténez-Marténez -- Antibiotic resistance in the absence of antimicrobial use / Lucia Pallecchi, Alessandro Bartoloni, Eduardo Gotuzzo & Gian Maria Rossolini -- Resistance in bacteria of the food chain : epidemiology and control strategies / Lina Maria Cavaco & Frank Møller Aarestrup -- Measures to prevent antimicrobial resistance / Vhairi M. Bateman & Ian M. Gould -- Where does novel antibiotics R&D stand among other pharmaceutical products? / Glenn S. Tillotson -- Resistance to antiretroviral drugs / Manuela Colafigli, Simona Di Giambenedetto & Roberto Cauda -- Index.
  • In vivo target site concentrations are probably the most important determinant of drug effects. Traditionally, linking drug concentrations to drug effects has been accomplished by modelling blood-derived data, mostly because a direct quantification of tissue concentrations has been beyond technical reach. Today, a direct measurement of target site concentrations is possible by employing microdialysis or complementary approaches such as imaging technologies. Microdialysis, initially conceived in the 1970s, has become a standard tool in drug development. This comprehensive overview of current microdialysis technology covers general and disease-specific aspects of microdialysis by international experts in the field. It provides useful information for colleagues in academia and industry who are interested PK-PD aspects of drug development.
  • "MicroRNAs are small, non-coding RNA molecules that interact with target mRNAs to modulate their translation. They are now recognized as widespread and critical regulators of gene expression in the cell. This book is aimed at both industry- and academic-based researchers in the Biopharmaceutical production space who wish to learn more about these fascinating molecules..."--Page [4] of cover.
  • 1. Microspheres for enzyme immobilization / Fei Gao, Yuxia Wang, and Guanghui Ma -- 2. Microspheres for cell culture / Weiqing Zhou, Guanghui Ma, and Zhiguo Su -- 3. Microcapsules for cell transplantation : design, preparation, and application / Guojun Lv, Ying Zhang, Mingqian Tan, Hongguo Xie, and Xiaojun Ma -- 4. Microspheres for the separation and refolding of proteins with an emphasis on particles made of agarose / Jan-Christer Janson -- 5. Microspheres for separation of bioactive small molecules / Fangling Gong, Guifeng Zhang, and Zhiguo Su -- 6. Microspheres for separation of PEG-modified biomolecules / Yongdong Huang, Yanqin Zhai, and Zhiguo Su -- 7. Microspheres for solid-phase organic synthesis / Jing Zhang and Zhiguo Su -- 8. Microspheres for solid-phase modification of proteins / Tao Hu and Zhiguo Su -- 9. Microspheres and microcapsules for protein drug delivery / Lianyan Wang, Tingyuan Yang, and Guanghui Ma -- 10. Micro/nanospheres for gene drug delivery / Jie Wu and Guanghui Ma -- 11. Microspheres for targeting delivery of anticancer drugs / Wei Wei, Zhanguo Yue, Hua Yue, and Guanghui Ma -- 12. Microspheres for targeting delivery to brain / Chen Jiang, Xinguo Jiang, Yang Liu, Kun Shao, and Rongqin Huang -- 13. Nano/microspheres in bioimaging and medical diagnosis / Xiaohui Li and Chunying Chen -- 14. Affinity nanoparticles for detection / Haruma Kawaguchi and Hiroshi Handa.
  • "Preface Over the past few decades, molecular modeling (MM) has become an important tool in many academic institutions and industrial laboratories. While the role of MM in biological fields--especially in the design and development of novel drug molecules or formulations--is well established and acknowledged, its direct role in the design and development of performance chemicals and novel materials is still not well known. Questions such as, which new products have resulted from an MM-based approach? are still often asked. Although MM may be playing an important role in product development, quite often it becomes difficult to predict its direct impact because most of the time the problem being addressed involves a multidisciplinary approach. Further, the assumption that fundamental phenomena being modeled though MM will have a direct impact on the macroscopic and functional properties of a product make the situation more complicated. In most of the cases, MM actually works as an enabler toward novel product and material development (e.g., novel drug molecules in biological application) rather than directly coming up with new products and materials. This precisely is the reason that despite seeing value in MM tools, most engineers and practitioners are often focus on the question, how do I leverage these tools to design and develop novel materials or chemicals for the industry I am working with? Unfortunately, there is no simple answer to this question. Excellent books and very good research publications highlight the most intricate, fundamental, and theoretical details about MM techniques and tools"-- Provided by publisher.
  • "Preface Drug development, aiming at improving people's health, becomes more costly every year. The pharmaceutical industry must join its efforts with government and health professions to seek new, innovative, and cost- effective approaches in the development process. During this evolutionary process in the next decades, computer simulations will no doubt play a critical role. Computer simulation or Monte Carlo is the technique of simulating a dynamic system or process using a computer program. Computer simulations, as an efficient and effective research tool, have been used virtually in every concern of engineering, science, mathematics, etc. In this book, I am going to present the concept, theory, algorithm, and cases studies of Monte Carlo simulation in the pharmaceutical and health industries. The concepts refer not only to simulation in general, but also to various types of simulations in drug development. The theory will include virtual data sampling, game theory, deterministic and stochastic decision theories, adaptive design methods, Petrinet, genetic programming, resampling methods, and other strategies. These theories and methods either are necessary to carry out the simulations or make the simulations more efficient, even though there are many practical problems that can be simulated directly in ad hoc fashion without any theory of their efficiency or convergence considerations. The algorithms, which can be descriptive, computer pseudocode, or a combination of both, provide the basis for implementation of simulation methods. The case studies or applications are the simplified versions of the real world problems. These simplifications are necessary because a single case could otherwise occupy the whole book, preventing readers from exploring broad issues"--Provided by publisher.
  • Ideal for chairside use by the entire dental team, Mosby's Dental Drug Reference, 11th Edition, provides the current, concise, dental-specific drug information you need at the point of care. More than 850 drug monographs make it easy to find indications and dosages, contraindications, interactions, side effects, serious reactions, and dental considerations. A companion website adds regular drug updates, a full-color pill atlas, printable patient education handouts, reference tables, and more. More than 850 drug monographs offer the vital dental-specific drug information you need.Drug information with relevant patient and family education guidelines in each monograph emphasize oral health, prevention, and treatment from the dental hygiene perspective.Durable and pocket sized, a succinct and organized format makes this guide ideal for chairside use. Bulleted lists provide quick and easy access to general and specific dental-related information in each monograph. .Primers on therapeutic management of common diseases and on medically compromised patients offer key foundational information relevant to the treatment of all patients.New monographs, FDA updates, a color pill atlas, images of common pathologic conditions, patient education handouts, quick-reference guides, and more are available online to help keep this guide compact and user-friendly.
  • 1. Multiplicity problems in clinical trials : a regulatory perspective / Mohammad Huque and Joachim Rèohmel -- 2. Multiple testing methodology / Alex Dmitrienko ... [et al.] -- 3. Multiple testing in dose-response problems / Frank Bretz, Ajit C. Tamhane, and Josâe Pinheiro -- 4. Analysis of multiple endpoints in clinical trials / Ajit C. Tamhane and Alex Dmitrienko -- 5. Gatekeeping procedures in clinical trials / Alex Dmitrienko and Ajit C. Tamhane -- 6. Adaptive designs and confirmatory hypothesis testing / Willi Maurer, Michael Branson, and Martin Posch -- 7. Design and analysis of microarray experiments for pharmacogenomics / Jason C. Hsu ... [et al.].
  • Nanoparticulate drug-delivery systems: an overview / Deepak Thassu, Yashwant Pathak and Michel Deleers -- Nanosuspensions for parenteral delivery / Barrett E. Rabinow -- Nanoparticles prepared using natural and synthetic polymers / Sudhir S. Chakravarthi, Dennis H. Robinson and Sinjan De -- Nanofiber-based drug delivery / Matthew D. Burke and Dmitry Luzhansky -- Drug nanocrystals - the universal formulation approach for poorly soluble drugs / Jan Möschwitzer and Rainer H. Müller -- Lipid-based nanoparticulate drug delivery systems / Jun Wu, Xiaobin Zhao and Robert J. Lee -- Nanoengineering of drug delivery systems / Ashwath Jayagopal and V. Prasad Shastri -- Aerosol flow reactor method for the synthesis of multicomponent drug nano- and microparticles / Janne Raula ... [et al.] -- Supercooled smectic nanoparticles / Heike Bunjes and Judith Kuntsche -- Biological and engineering considerations for developing tumor-targeting metallic nanoparticle drug-delivery systems / Giulio F. Paciotti and Lawrence Tamarkin -- Biological requirements for nanotherapeutic applications / Joseph F. Chiang -- Role of nanobiotechnology in the development of nanomedicine / K.K. Jain -- Pharmaceutical applications of nanoparticulate drug-delivery systems / Yashwant Pathak, Deepak Thassu and Michel Deleers -- Lipid nanoparticles (solid lipid nanoparticles and nanostructured lipid carriers) for cosmetic, dermal, and transdermal applications / Eliana B. Souto and Rainer H. Müller -- Nano-carriers of drugs and genes for the treatment of restenosis / Einat Cohen-Sela ... [et al.] -- Ocular applications of nanoparticulate drug-delivery systems / Annick Ludwig -- Nanoparticulate systems for central nervous system drug delivery / Jean-Christophe Olivier and Manuela Pereira de Oliveira -- Nanoparticles for gene delivery: formulation characteristics / Jaspreet K. Vasir and Vinod Labhasetwar -- Gastrointestinal applications of nanoparticulate drug-delivery systems / Maria Rosa Gasco -- Nanoparticles as adjuvant-vectors for vaccination / Socorro Espuelas ... [et al.] -- Transdermal applications of nanoparticulates / Jongwon Shim.
  • This volume tries to put current therapy - achievements, shortcomings, remaining medical needs - and emerging new targets into the context of increasing knowledge regarding the genetic and neurodevelopmental contributions to the pathophysiology of schizophrenia. Some of the chapters also deal with respective experimental and clinical methodology, biomarkers, and translational aspects of drug development. The volume concentrates on reviewing the ongoing research attempting to identify novel treatments for the cognitive deficits and negative symptoms of schizophrenia, which are not treated adequately by current antipsychotic medications.
  • Omics for Personalized Medicine will give to its prospective readers the insight of both the current developments and the future potential of personalized medicine. The book brings into light how the pharmacogenomics and omics technologies are bringing a revolution in transforming the medicine and the health care sector for the better. Students of biomedical research and medicine along with medical professionals will benefit tremendously from the book by gaining from the diverse fields of knowledge of new age personalized medicine presented in the highly detailed chapters of the book. The book chapters are divided into two sections for convenient reading with the first section covering the general aspects of pharmaocogenomic technology that includes latest research and development in omics technologies. The first section also highlights the role of omics in modern clinical trials and even discusses the ethical consideration in pharmocogenomics. The second section is focusing on the development of personalized medicine in several areas of human health. The topics covered range from metabolic and neurological disorders to non-communicable as well as infectious diseases, and even explores the role of pharmacogenomics in cell therapy and transplantation technology. Thirty-four chapters of the book cover several aspects of pharmacogenomics and personalized medicine and have taken into consideration the varied interest of the readers from different fields of biomedical research and medicine. Advent of pharmacogenomics is the future of modern medicine, which has resulted from culmination of decades of research and now is showing the way forward. The book is an honest endeavour of researchers from all over the world to disseminate the latest knowledge and knowhow in personalized medicine to the community health researchers in particular and the educated public in general.
  • Antibacterial agents -- Antifungal agents -- Antiviral agents -- Anti-parasitic agents -- Anti-glaucoma agents -- Neuro-ophthalmology -- Anti-inflammatory agents -- Mydriatics, cycloplegics, and reversal agents -- Lubricants and viscoelastics -- Miscellaneous -- Anti-angiogenesis agents -- Contact lens solutions.
  • Thoroughly revised and updated, Optimization in Drug Discovery: In Vitro Methods, Second Edition presents a wide spectrum of in vitro assays including formulation, plasma binding, absorption and permeability, cytochrome P450 (CYP) and UDP-glucuronosyltransferases (UGT) metabolism, CYP inhibition and induction, drug transporters, drug-drug interactions via assessment of reactive metabolites, genotoxicity, and chemical and photo-mutagenicity assays. Written for the Methods in Pharmacology and Toxicology series, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible protocols, and tips on troubleshooting and avoiding known pitfalls. Expert authors have developed and utilized these in vitro assays to achieve drug-like characteristics in addition to efficacy properties and good safety profiles of drug candidates. Comprehensive and up-to-date, Optimization in Drug Discovery: In Vitro Methods, Second Edition aims to guide researchers down the difficult path to successful drug discovery and development.
  • "This book summarizes the state of the art in process analytical technologies applied to various aspects of biopharmaceutical process development and manufacturing. The text summarizes regulatory perspectives, FDA/EMEA guidelines, and new expectations. In addition, it explores new technology, especially in the area of real-time monitoring for end-point control as well as new sensor and analytical technologies. It details established and emerging measurement technologies, including future needs and challenges that require further research. The authors also present successful industrial-scale deployment case studies and strategies from the biopharmaceutical industry and discuss future trends"-- Provided by publisher.
  • The Path from Biomarker Discovery to Regulatory Qualification is a unique guide that focuses on biomarker qualification, its history and current regulatory settings in both the US and abroad. This multi-contributed book provides a detailed look at the next step to developing biomarkers for clinical use and covers overall concepts, challenges, strategies and solutions based on the experiences of regulatory authorities and scientists. Members of the regulatory, pharmaceutical and biomarker development communities will benefit the most from using this book-it is a complete and practical guide to biomarker qualification, providing valuable insight to an ever-evolving and important area of regulatory science. Contains a collection of experiences of different groups taking different types of biomarkers to different levels of qualification and provides insightful case studies of an important area of regulatory science Focuses on practical advice, concepts, strategies and overall outcomes to support those working toward biomarker qualification for clinical use Offers a valuable resource for members of the regulatory, pharmaceutical and biomarker development communities.
  • As the first book that specifically addresses pediatric formulations in the context of drug development, Pediatric Formulations: A Roadmap covers anatomy and physiology of children as well as the technical state of the art, gives hints about where to find inspiration, and provides a suitable background on the regulatory framework. Existing books on pediatric formulations mainly discuss compounding at the pharmacy. This is not a "how to formulate" textbook for pharmaceutical scientists; the subtitle "A Roadmap" indicates that we are on a path in largely unexplored territory. It is an attempt to equip the reader with necessary information on how to get started with the appropriate mindset. Among medicinal specialties, pediatrics is a young discipline. The potential dangers of medicine were often underestimated in earlier times. Cough suppressants labeled as "suitable for children and adults" a hundred years ago could kill children as they contained opioids. Since then, a complex framework has evolved, with physicians, pharmacists, drug development companies, generic companies, academic scientists, regulatory authorities, reimbursement organizations, patients and children's parents as key players. The position of children in our society has changed dramatically during the last century. Children were protected against clinical trials, yet thanks to clinical trials, many more children with cancer survive today. The development of age-adjusted drug formulations is not only a technical challenge. For new drugs today, there are laws both in the United States and the European Union that compel the research-based pharmaceutical industry to also consider children during drug development. One of the major demands of authorities is the development of age-appropriate formulations.
  • The pharmaceutical industry needs a shot in the arm - and not a moment too soon. The executive suite is mired in a bygone era, a time when extensive, well-funded pharmaceutical R & D produced blockbuster drugs, kept everything in-house and reaped the financial rewards. But that way of working needs to change. Executives now need to know what the technologists in their companies are doing in order to survive the next decade. Written for those new to industry, as well as for experienced professionals or specialists looking to expand their knowledge, this book is a must-read for business executive.
  • Introduction to Competitive Intelligence -- Overall Perspective of Due Diligence Investigations and Processes -- The Regulatory Functional Review: Primary Roles -- The On-Site Due Diligence/Data Room Meeting and Interactions with Other Functional Area Experts -- Intellectual Property -- The Final Report -- Competitive Intelligence Summary.
  • Introduction to experimental design -- Comparison of mean values -- Nonparametric methods -- Regression and correlation -- Multivariate methods -- Factorial design of experiments -- Response-surface methodology -- Model-dependent optimization -- Sequential methods and model-independent optimization -- Experimental designs for mixtures -- Artificial neural networks and experimental design.
  • 1. Overview of Medicines Regulatory Systems in the Gulf Region -- 2. The Regulatory Review Process in the Gulf Region -- 3. Regulatory Review Times in the Gulf Region -- 4. Quality Measures in the Gulf Regulatory Practices -- 5. The Current Status of the Common Technical Document -- 6. The Current Status of Drug Safety and Pharmacovigilance -- 7. The Centralized Regulatory Review in the Gulf Region -- 8. The Gulf States Assessment and Experience With the Centralised Procedure -- 9. The Pharmaceutical Companies Assessment and Experience With the Centralised Procedure -- 10. Proposal For an Improved Centralized Regulatory System -- 11. The Strategic Planning Process of the GCC Regulatory Authorities: Barriers And Solutions -- 12. The Regulatory Dilemma in the Gulf Region: The Way Forward.
  • Contains proceedings of the AAPS Stability Workshop.
  • 2007 ProQuest Safari
    Statistics in drug development by Christy Chuang-Stein and Ralph D'Agostino -- Modern classification methods for drug discovery by Kjell Johnson and William Rayens -- Model building techniques in drug discovery by Kimberly Crimin and Thomas Vidmar -- Statistical considerations in analytical method validation by Bruno Boulanger, Viswanath Devanaryan, Walthère Dewé, and Wendell Smith -- Some statistical considerations in nonclinical safety assessment by Wherly Hoffman, Cindy Lee, Alan Chiang, Kevin Guo, and Daniel Ness -- Nonparametric methods in pharmaceutical statistics by Paul Juneau -- Optimal design of experiments in pharmaceutical applications by Valerii Fedorov, Robert Gagnon, Sergei Leonov, and Yuehui Wu -- Analysis of human pharmacokinetic data by Scott Patterson and Brian Smith -- Allocation in randomized clinical trials by Olga Kuznetsova and Anastasia Ivanova -- Sample-size analysis for traditional hypothesis testing: concepts and issues by Ralph G. O'Brien and John Castelloe -- Design and analysis of dose-ranging clinical studies by Alex Dmitrienko, Kathleen Fritsch, Janson Hsu, and Stephen Ruberg -- Analysis of incomplete data by Geert Molenberghs, Caroline Beunckens, Herbert Thijs, Ivy Jansen, Geert Verbeke, Michael Kenward, and Kristen Van Steen -- Reliability and validity: Assessing the psychometric properties of rating scales by Douglas Faries and Ilker Yalcin -- Decision analysis in drug development by Carl-Fredrik Burman, Andy Grieve, and Stephen Senn.
  • Advances in drugs and biologics to mitigate or cure some of nature's most complex medical problems have been incredible to behold. These accomplishments are due to the actions of a wide theatre of participants from biologists, pharmacologists, geneticists, chemists and manufacturers, molecular biologists, toxicologists, clinicians, nurses, program managers, quality assurance personnel, regulatory professionals and a new group of innovators the Imaging Scientists. Imaging has grown from the microscopy sections put on slides with special stains to now in vivo slices created with innovative physics, imaging tracers and contrast agents, and incredibly fast and accurate computational systems. The world of biology has become one of witnessing the actions of drugs and biologics through the window of mechanical and electrical engineering creating instruments and reporter molecules that can help us see into our bodies and paint them with medical information needed to resolve disease. This book will inspire imagination and elicit even more innovations in the development of new and novel drugs and biologics through imaging.
  • Pharmacogenomics : historical perspective and current status / Rosane Charlab and Lei Zhang -- Denaturing high-performance liquid chromatography for mutation detection and genotyping / Donna Lee Fackenthal [and others] -- Clinical SNP detection by the smartAmp method / Toshihisa Ishikawa and Yoshihide Hayashizaki -- MALDI-TOF mass spectrometry / Dirk van den Boom, Matthias Wjst, and Robin E. Everts -- TaqMan® drug metabolism genotyping assays for the detection of human polymorphisms involved in drug metabolism / Toinette Hartshorne -- Pyrosequencing of clinically relevant polymorphisms / Cristi R. King and Sharon Marsh -- Pharmacogenetics using Luminex® xMAP® technology : a method for developing a custom multiplex single nucleotide polymorphism mutation assay / Gonnie Spierings and Sherry A. Dunbar -- Use of linkage analysis, genome-eide association studies, and next-generation sequencing in the identification of disease-causing mutations / Eric Londin [and others] -- GoldenGate genotyping assay : custom design, processing, and data analysis / Anna González-Neira -- Genome-wide gene expression profiling, genotyping, and copy number analyses of acute myeloid leukemia using affymetrix geneChips. / Mathijs A. Sanders and Peter J.M. Valk -- Epigenetic techniques in pharmacogenetics / Sandra G. Heil -- Plasmid derived external quality controls for genetic testing / Tahar van der Straaten and Henk-Jan Guchelaar -- Allelic imbalance assays to quantify allele-specific gene expression and transcription factor binding / Francesca Luca and Anna Di Rienzo -- SCAN : a systems biology approach to pharmacogenomic discovery / Eric R. Gamazon, R. Stephanie Huang, and Nancy J. Cox -- Methods to examine the impact of nonsynonymous SNPs on protein degradation and function of human ABC transporter / Toshihisa Ishikawa, Kanako Wakabayashi-Nakao, and Hiroshi Nakagawa -- In vitro identification of cytochrome P450 enzymes responsible for drug metabolism / Zhengyin Yan and Gary W. Caldwell -- In vitro and in vivo mouse models for pharmacogenetic studies / Amber Frick [and others] -- Hydrodynamic tail vein assay as a tool for the study of liver promoters and enhancers / Mee J. Kim and Nadav Ahituv -- Guide to the current web-based resources in pharmacogenomics / Dylan M. Glubb [and others] -- PharmGKB : the pharmacogenomics knowledge base / Caroline F. Thorn, Teri E. Klein, and Russ B. Altman -- Genetic databases in pharmacogenomics : the frequency of inherited disorders database (FINDbase) / Marianthi Georgitsi and George P. Patrinos -- Development of predictive models for estimating warfarin maintenance dose based on genetic and clinical factors / Lu Yang and Mark W. Linder -- Evidence based drug dosing and pharmacotherapeutic recommendations per genotype / Vera H.M. Deneer and Ron H.N. van Schaik.
  • Historical aspects of pharmacogenetics / Werner Kalow -- Pharmacogenomics and the promise of personalized medicine / Vural Ozdemir and Bernard Lerer -- Pharmacogenetics of drug metabolism: two clinically important polymorphic enzymes, CYP2D6 and TPMT / Georgios Panagiotidis and Leif Bertilsson -- Receptors / Wendell W. Weber -- Pharmacogenetics of drug transporters / Catia Marzolini, Rommel G. Tirona, and Richard B. Kim -- Variability in induction of human drug metabolizing enzymes / Allan B. Okey -- Pharmacogenetics and cardiac ion channels / Dan M. Roden -- Interethnic differences in drug response / Werner Kalow -- Clinical perspectives / Urs A. Meyer and David A. Flockhart -- Regulatory perspectives on pharmacogenomics / Lawrence J. Lesko and Janet Woodcock -- Tools of the trade: the technologies and challenges of pharmacogenetics / Glenn A. Miller -- Technologies for the analysis of single nucleotide polymorphisms - an overview / Denis M. Grant -- Molecular diagnostics / Tracy L. Stockley and Peter N. Ray --
  • This book is the 4th in a series of Acute Care books written with the aim to address the NEEDS of health care providers when handling the acutely ill patients. Globally it has become apparent that the study of pharmacology and subsequent clinical training has not always adequately equipped young doctors with the ability to administer drugs to their patients safely and confidently, particularly in the critically ill patient. Compounding this issue is the lack of resource material related to these pharmacological concepts contained in one book that can help health care providers to understand and manage drug therapy in the acute situation. In spite of progressively newer and more developed protocols, guidelines, algorithms and many other books addressing the technical aspects of what needs to be done, most health care providers still find it difficult to grasp the basic pharmacological knowledge and rationally deliver the CARE that is required in the acute phase of patient management. The editors/authors have therefore aimed for a book that highlights topics and pharmacological issues pertinent to management of patients in their hour of need. This is a multi-author book but the style has been guided by 3 editors. The editors have used a different perspective? that of normalizing abnormal physiological processes with pharmacological agents? to address the GAPS in a bedside to bench approach. The details are pared down but important principles/concepts are emphasized.
  • Cardiovascular pharmacotherapy is a fast-moving and complex discipline within cardiology in general. New studies, trials and indications are appearing on a regular basis. This series, and this particular title within the series, is designed to establish the baseline level of knowledge that a cardiovascular professional needs to know on a day-to-day basis. The information within is designed to allow readers to learn quickly and with certainty the mode of action, the possible adverse effects, and the management of patients prescribed these drugs.
  • Pharmacology. 4th ed. 2013
    Pharmacology, 4th Edition helps you master the "must-know" concepts in this subject and how they apply to everyday clinical problem solving and decision making. This concise yet comprehensive text clearly explains and illustrates challenging concepts and helps you retain the material - from course exams and the USMLE Step 1 right through to clinical practice. Quickly reference essential information thanks to abundant tables throughout, and drug classification boxes at the beginning of each chapter. See how pharmacology applies to practice with real-world case studies. Prepare for exams with self-assessment questions at the end of each chapter. Understand complex concepts visually with the aid of superb full-color illustrations. Access the complete contents online at, along with an additional glossary, chapter-by-chapter summaries and case studies, a full list of featured drugs, 150 USMLE-style questions, animations, and more.
  • Pharmacy Practice Research- Evidence and Impact -- Research Methodologies related to pharmacy practice: An Overview -- Quantitative Methods in Pharmacy Practice Research -- Qualitative Methods in Pharmacy Practice Research -- Action Research in Pharmacy Practice -- Participatory Action Research in Pharmacy Practice -- Mixed Methods Research in Pharmacy Practice -- Applying organizational theory in Pharmacy Practice Research -- Applying pharmacoeconomic methods in community and hospital pharmacy research -- Concept Mapping and pattern matching in pharmacy practice research -- Pharmacoepidemiological approaches in healthcare -- Future of Pharmacy Practice Research -- Pharmacists' attitudes towards pharmacy practice research: a review.
  • Placebo 2014
    Due to the recent explosion of placebo research at many levels the Editors believe that a volume on Placebo would be a good addition to the Handbook of Experimental Pharmacology series. In particular, this volume will be built up on a meeting on Placebo which will be held in Tuebingen (Germany) in January 2013, and where the most prominent researchers in this field will present and exchange their ideas. The authors who will be invited to write chapters for this volume will be the very same speakers at this meeting, thus guaranteeing high standard and excellence in the topic that will be treated. The approach of the book is mainly pharmacological, including basic research and clinical trials, and the contents range from different medical conditions and systems, such as pain and the immune system, to different experimental approaches, like in vivo receptor binding and pharmacological/behavioral conditioning. Overall, the volume will give an idea of modern placebo research, of timely concepts in both experimental and clinical pharmacology, as well as of modern methods and tools in neuroscience.
  • Preface -- Introduction -- Prescription assessment -- Availability of medicines -- Oral solids -- Oral liquids -- Pulmonary -- Oropharynx -- Nose -- Ear -- Eye -- Rectal and vaginal -- Dermal -- Parenteral -- Irrigation and dialysis -- Product design -- Biopharmaceutics -- Quality risk management -- Physical chemistry -- Microbiology -- Statistics -- Radiopharmacy -- Stability -- Raw materials -- Containers -- Human resources -- Occupational health and safety -- Premises -- Equipment -- Basic operations -- Sterilisation methods -- Aseptic handling -- Quality requirements and analysis -- Documentation -- Production, Validation Quality Control -- Quality systems -- Logistics -- Instructions for the use of medicines -- Impact on Environment -- Information sources -- Index.
  • Philosophical and Social Framework of Electronic Medicines Management -- History and Context of Electronic Prescribing in the US and UK -- Organization Benefits of Electronic Prescribing -- EP Systems as a Risk Management Tool -- Data Support for Electronic Medicines Management -- Electronic Medicines Management: Support for Professional Practice -- Electronic Medicines Management and Non-medical Prescribing -- Electronic Prescribing and Future Priorities.
  • Preface -- Part 1. An Overview of Safety Pharmacology and its Role in Drug Discovery -- Part 2. The Safety Pharmacology Core Battery -- Part 3. Supplemental Safety Pharmacology -- Part 4. Safety Pharmacology of Biological and Anticancer Pharmaceuticals -- Part 5. Clinical Safety Pharmacology.
  • Overview of the current process of new drug discovery and development / Charles G. Smith and James T. O'Donnell -- Integrated drug product development: from lead candidate selection to life-cycle management / Madhu Pudipeddi, Abu T.M. Serajuddin, and Daniel Mufson -- The impact of combinatorial chemistry on drug discovery / Michael H. Rabinowitz and Nigel Shankley -- High-throughput screening: enabling and influencing the process of drug discovery / Carol Ann Homon and Richard M. Nelson -- Pharmacological and pharmaceutical profiling: new trends / Joanne Bowes ... [et al.] -- Cell-based analysis of drug response using moving optical gradient fields / Jeff M. Hall ... [et al.]. -- Patient-derived primary cells in high-throughput differential antitumor screens: let the patients be the guide / Irwin A. Braude -- The evolving role of the caco-2 cell model to estimate intestinal absorption potential and elucidate transport mechanisms / Jibin Li and Ismael J. Hidalgo -- The promise of metabonomics in drug discovery / Harold J. Kwalwasser and Pauline Gee -- Pharmacogenetics and pharmacogenomics in drug development and regulatory decision-making: report of the first FDA-PWG-PhRMA-druSafe workshop / Lawrence J. Lesko ... [et al.] -- Drugs from molecular targets for CNS and neurodegenerative diseases / William T. Comer and Gönül Veliçelebi -- Safety pharmacology / Jean-Pierre Valentin and Tim G. Hammond -- Nonclinical drug safety assessment / Frederick E. Reno -- Preclinical genotoxicity testing: past, present and future / Richard H.C. San -- The need for animals in biomedical research / Charles G. Smith -- Defining the actual research approach to the new drug substance / Charles G. Smith -- Pharmacokinetics: pharmacodynamics in new drug development / Sarfaraz K. Niazi -- Pharmaceutics and compounding issues in new drug development and marketing / Loyd V. Allen -- Late stage and process development activities / Charles G. Smith -- Contract research organizations: role and function in new drug development / F. Richard Nichol -- The front lines of clinical research: the industry / Lori Nesbitt -- Horizons for cancer chemotherapy (and nonchemotherapy) / Daniel D. Von Hoff -- Human immunodeficiency virus/acquired immune deficiency syndrome: clinical testing challenges / Vincent Idemyor -- Common technical document: the changing face of the new drug application / Justina A. Molzon -- Electronic publishing / Heather L. Wallace -- The important role of pharmacists in a complex risk-management system: managing the risks from medical product use by focusing on patient education, monitoring, and adverse event reporting / Justina A. Molzon -- Liability, litigation, and lessons in new drug development / James T. O'Donnell -- Problems in the nondrug marketplace / Stephen Barrett -- Patents and new product development in the pharmaceutical and biotechnology industries / Henry Grabowski -- The pharmaceutical revolution: drug discovery and development / John C. Somberg -- The discovery of Rituxan / Mitchell E. Reff -- Funding the birth of a drug: lessons from the sell side / Howard E. Greene -- Innovations for the drug development pathway: what is needed now / Janet Woodcock -- Managing R & D uncertainty and maximizing the commercial potential of pharmaceutical compounds using the dynamic modeling framework / Mark Paich ... [et al.].
  • Harvest of a therapeutic protein product from high cell density fermentation broths : principles and case study / Elisabeth Russell, Alice Wang, and Anurag S. Rathore -- Expanded bed adsorption for capture from crude solution / Alan Sonnenfeld and Jorg Thommes -- Product recovery by high-gradient magnetic fishing / Matthias Franzreb ... [et al.] -- Protein refolding and scale up / Cynthia Cowgill, Asuman G. Ozturk, and Richard St. John -- Bulk protein crystallization, principles and methods / Mark R. Etzel -- Modes of preparative chromatography / Abhinav A. Shukla and Yinges Yigzaw -- Screening of chromatographic stationary phases / Abhinav A. Shukla and Xuejun Sean Han -- A priori prediction of chromatographic separations from protein structure data / Asif Ladiwala, Curt M. Breneman, and Steven M. Cramer -- Membrane chromatography : analysis of breakthrough curves and viral clearance / Mark R. Etzel and William T. Riordan -- Ultrafiltration process design and implementation / Herb Lutz and Bala Raghunath -- Virus filtration process design and implementation / Michael W. Phillips ... [et al.] -- Product recovery from transgenic sources / Chenming (Mike) Zhang and Kevin E. Van Cott -- Analytical strategy for biopharmaceutical development / Drew N. Kelner and Mahesh K. Bhalgat -- Evaluation of viral clearance in purification processes / Amitava Kundu and Karl Reindel -- Advances in viral clearance / Kurt Brorson -- Protein A affinity chromatography for capture and purification of monoclonal antibodies and Fc-fusion proteins: practical considerations for process development / Sanchayita Ghose, Thomas McNerney, and Brian Hubbard -- Polishing methods for monoclonal IgG purification / Pete Gagnon -- Making changes to a biopharmaceutical manufacturing process during development and commercial manufacturing : the REMICADE story / Peter W. Wojciechowski ... [et al.] -- Linear scale-up of ultrafiltration of high viscosity process streams / Christopher Daniels ... [et al.] -- A membrane chromatography application : a rapid, high capacity gene therapy vector purification tool / Ajay R. Lajmi, Robert Kutner, and Jakob Reiser.
  • Radiotracers and drug registration -- Radioactivity and radiotracers -- The study of drug metabolism using radiotracers -- DNA binding, isotope dilution and other uses of radiotracers -- Quantitative whole-body autoradiography (QWBA) -- Scintillation counting -- Statistics in liquid scintillation counting -- Instrumentation for detection of radioactivity -- Sample preparation for liquid scintillation counting -- Biomedical accelerator mass spectrometry -- Positron emission tomography -- Gamma scintigraphy and SPECT.
  • The drug discovery business to date -- The drug discovery business to come -- Industrial considerations -- how things get done : the project team -- Project considerations -- Hit generation -- Turning hits into drugs -- Initial properties -- ADME and PK properties -- Toxicity related properties -- A career in drug discovery research.
  • As the population of patients with acute or chronic kidney disease grows, healthcare professionals need a resource that optimizes drug effectiveness while minimizing potential toxicity. Renal Pharmacotherapy is a comprehensive listing of dosage recommendations for patients with compromised renal function. This up-to-date and evidence-based reference closes several identified knowledge gaps concerning medications eliminated by the kidneys. Conveniently listed alphabetically by generic drug name, each drug has its own face page featuring typical dosing ranges, alternative dosing adjustments by strata of renal function, specific dosing for dialysis and other dosing schemes.This work will satisfy the dosing information needs of busy physicians involved in pharmacotherapy for patients with kidney disease, as well as pharmacists, nurses and students.
  • Introduction -- pt. I. Background to drug discovery and development -- pt. II. The drug development pipeline: discovery to testing in humans -- pt. III. The drug development pipeline: clinical trials to marketing authorization -- pt. IV. The global pharmaceuticals business -- pt. V. Professional interactions with drug discovery industry.
  • The enormous initial mistake -- The origins of six sigma -- Evolution -- Revolution -- Paradox -- Action and reaction -- Close enough or on target? -- Make more-- faster! -- Case studies -- The camera always lies -- Keeping it simple -- Why use control charts? -- Average and range control charts -- Origins and theory -- Charts for individuals -- Practical considerations -- Improving laboratories -- Beyond compliance.
  • Introduction -- Accelerated testing -- Expiration dating period -- Stability designs -- Stability analysis with fixed batches -- Stability analysis with random batches -- Stability analysis with a mixed effects model -- Stability analysis with discrete responses -- Stability analysis with multiple components -- Stability analysis with frozen drug products -- Stability testing for dissolution -- Current issues and recent development.
  • This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines, Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures, Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development.
  • Stratified medicine : a new challenge for academia, industry, regulators and patients -- Stratified medicine : a new era in the therapeutic approach -- Challenges for academic medicine and clinicians -- Challenges for diagnostics industry -- Challenges for the pharmaceutical industry -- Separate or codevelopment of biomarker and drug : the scenarios -- Challenges for the regulatory agencies in establishing an environment favorable for stratified medicine -- Challenges for the patients facing stratified medicine & personal genomics -- Conclusions & outlook to the future health system -- Stratified medicine : a challenging social experiment.
  • The SFC market : "yesterday, today, and tomorrow" -- The use of SFC in discovery sciences -- Qualification of SFC hardware and validation of systems -- Method development for achiral SFC -- Achiral preparative supercritical fluid chromatography -- Supercritical fluid chromatography for chiral method development screening and analysis -- Chiral preparative supercritical fluid chromatography -- SFC in process analytical chemistry -- Analytical SFC for impurities -- Supercritical fluid chromatography -- mass spectrometry -- Supercritical fluid chromatography of natural products -- Polarimetric detection in supercritical fluid chromatography -- Supercritical fluid chromatography with ultra-performance particles -- Pilot and production-scale supercritical fluid chromatography.
  • Part I. Systems biology in cancer -- Part II. Systems approaches to understand cancer progression -- Part III. Systems and network biology in decoding miRNA complexity -- Part IV. Network modeling in cancer drug discovery and clinical trials.
  • Methods of data representation, interpretation, and analysis / Craig K. Svensson and Tapash K. Ghosh -- Thermodynamics and states of matter / Adam M. Persky, Laszlo Prokai, and Jeffrey A. Hughes -- Solubility / Jeffrey A. Hughes .. [et al.] -- Physiochemical factors affecting biological activity / Hemant Alur ... [et al.] -- Micromeritics and rheology / Sunil S. Jambhekar -- Principles and applications of surface phenomena / Laszlo Prokai ... [et al.] -- Theory and applications of diffusion and dissolution / Xiaoling Li and Bhaskara Jasti -- Chemical kinetics and stability / Tapash K. Ghosh -- Drug and dosage form development: regulatory perspectives / Edward Dennis Bashaw -- Oral conventional solid dosage forms: powders and granules, tablets, lozenges, and capsules / Melgardt M. de Villiers -- Oral controlled release solid dosage forms / Emmanuel O. Akala -- Oral liquid dosage forms: solutions, elixirs, syrups, suspensions, and emulsions / William M. Kolling and Tapash K. Ghosh -- Parenteral routes of delivery / Yon Rojanasakul and Carl J. Malanga -- Transdermal and topical drug delivery systems / Bhaskara R. Jasti, William Abraham, and Tapash K. Ghosh -- Rectal and vaginal routes of drug delivery / Nikhil R. Shitut .. [et al.] -- Ocular, nasal, pulmonary, and otic routes of drug delivery / Harisha Atluri ... [et al.] -- Delivery of peptide and protein drugs / Emily Ha ... [et al.].
  • Section I. A theory of evaluating drugs -- section II. A theory of evidence in drug development -- section III. Additional topics.
  • 2012 ClinicalKey
    Therapeutic Drug Monitoring: Newer Drugs and Biomarkers features timely topics such as the monitoring of classical and newer drugs, pharmacogenomics and the application of biomarkers in therapeutic drug monitoring. This reference also discusses the limitations of current commercially available immunoassays for therapeutic monitoring. It presentsssnew and sophisticated techniques used for proper determination of blood levels and the clinical utility of therapeutic drug monitoring of contemporary drugs. Written by leading international experts and geared toward clinical pathol.
  • Overview of drug development / James A. Popp and Jeffery A. Engelhardt -- Nonclinical safety evaluation of drugs / Thomas M. Monticello and Jeanine L. Bussiere -- Toxicokinetics and drug metabolism : relating toxicity to compound exposure and disposition / David D. Christ -- Introduction to toxicologic pathology / Judit E. Markovits ... [et al.] -- Routine and special techniques in toxicologic pathology / Daniel J. Patrick, Peter C. Mann -- Principles of clinical pathology / Robert L. Hall -- Toxicogenomics in toxicologic pathology / Mark J. Hoenerhoff and David E. Malarkey -- Spontaneous lesions in control animals used in toxicity studies / Robert C. Johnson, Robert H. Spaet, Daniel L. Potenta -- Gastrointestinal tract / Judit E. Markovits -- Liver, gall bladder, and exocrine pancreas / Russell C. Cattley, James A. Popp, Steven L. Vonderfecht -- Respiratory system / David J. Lewis and Tom P. McKevitt -- Urinary system / Kendall S. Frazier and John Curtis Seely -- Hematopoietic system / Kristin Henson, Glenn Elliott, Gregory S. Travlos -- The lymphoid system / Patrick J. Haley -- Bone, muscle, and tooth / John L. Vahle ... [et al.] -- The cardiovascular system / Calvert Louden, David Brott -- Endocrine glands / Sundeep Chandra, Mark Hoenerhoff, Richard Peterson -- Reproductive system and mammary gland / Justin D. Vidal ... [et al.] -- Skin / Zbigniew Wojcinski ... [et al.] -- Nervous system / Mark T. Butt, Robert Sills, Alys Bradley -- Special senses : eye and ear / James A. Render, Kenneth A. Schafer, Richard A. Altschuler.
  • Chapter 1. Introduction to Translational Medicine -- Chapter 2. New Light Through an Old Window? The "Translational Turn" in Biomedical Research -- Chapter 3. Translational Medicine -- Drivers and Barriers of TM -- Chapter 5. Developing an Evaluation Model for Translational Medicine Research Programs -- Chapter 6. Emerging Concepts in Biomarker Discovery -- Chapter 7. Imaging Biomarkers for Innovative Drug Development -- Chapter 8. Translational Bioinformatics -- Chapter 9. Exploiting Translational Medicine Through Public- Private Partnerships -- Chapter 10. The Role of the Product Development Partnership as a Translational Mechanism for Delivering Health Solutions in Low- Resource Settings.
  • Transporters in Drug Development is a corner stone in a high profile book series on advances in pharmaceutical sciences initiated by AAPS, Springer and Professor Daan Crommelin as series Editor. Transporters in Drug Development: Discovery, Optimization, Clinical Study and Regulation list chapters written by leading researchers in the transporter field from academia, pharmaceutical industry and medicines agencies. The book encompasses examples and advises on how membrane transporters can be dealt with in academic industrial drug discovery and pharmaceutical development as well as from a regulatory perspective. Methods and examples of in vitro characterization of single transporters in intestine, liver and kidney are described as well as characterization of substrate overlap between various transporters. Furthermore, probes and biomarkers are suggested for studies of the transporters impact on the pharmacokinetics of drug substrates/candidates interacting on transporters. The challenges of translating in vitro observed interaction of transporters into in vivo relevance are discussed as well as the perspectives of applying targeted proteomics and mechanistic modelling in this process.
  • TRP channels in drug discovery v.1-2=, 2012
    Springer Protocols
    2nd ed., 2014 Springer Protocols
    V. 1. Introduction to TRPs : a quest for novel drug targets / Bernd Nilius -- TRP-mediated cytoskeletal reorganization : implications for disease and drug development / Chandan Goswami -- TRPA1 in drug discovery / Jun Chen, Steve McGaraughty, and Philip R. Kym -- Canonical transient receptor potential channel expression, regulation, and function in vascular and airway diseases / Brij B. Singh, Christina M. Pabelick, and Y.S. Prakash -- TRPM2 function and potential as a drug target / Barbara A. Miller -- Ca2+-activated monovalent cation-selective channels TRPM4 and TRPM5 / Barbara Colsoul ... [et al.] -- Emerging role of TRPM7 in the regulation of magnesium homeostasis / Vladimir Chubanov ... [et al.] -- TRPM8 channels as potential therapeutic targets for pain, analgesia, and thermoregulation / David D. McKemy -- TRPML channels in function, disease, and prospective therapies / David A. Zeevi -- TRPP signaling module : TRPP2/polycystin-1 and TRPP2/PKD1L1 / Alexis Hofherr -- TRPV1 as a polymodal sensor : potential to discover TRPV1 antagonists selective for specific activating modalities / Olivier Radresa ... [et al.] -- Nociceptive and nonnociceptive roles of TRPV3 and its "druggability" / Sungjae Yoo and Sun Wook Hwang -- TRPV4 and drug discovery / Fabien Vincent and Matthew A.J. Duncton -- TRP expression and function in the lung airways / Alexander Dietrich and Thomas Gudermann -- Hypoxia-dependent TRP channel function in pulmonary arterial smooth muscle cells / Beate Fuchs ... [et al.] -- Endotoxin-induced airway inflammation and asthma models / Zsuzsanna Helyes and Zsofia Hajna -- Enhanced cough, animal models / Raffaele Gatti ... [et al.] -- Capsaicin inhalation test in man / Eva Millqvist -- TRP channels in the genitourinary tract / Ana Charrua and Francisco Cruz -- Animal models of cystitis / Celia D. Cruz and Antonio Avelino -- Overactive bladder models / Roberto Soler ... [et al.] V. 2. TRPs to cardiovascular disease / José C. González-Cobos, Xuexin Zhang, Rajender K. Motiani, Kelly E. Harmon, and Mohamed Trebak -- Anemic zebrafish models of cardiomyopathy / Xiaojing Sun and Xiaolei Xu -- Methods to study the effects of TRP channel drugs on vascular endothelial cell function / Yan Ma, Yung-Wui Tjong, and Xiaoqiang Yao -- Atherosclerosis models with cell-mediated calcification / Beili Zhu -- Models of hypertension and blood pressure recording / Luciana Aparecida Campos and Ovidiu Constantin Baltatu -- Balloon injury in rats as a model for studying TRP channel contribution to vascular smooth muscle remodeling / Wei Zhang and Mohamed Trebak -- TRP channels in the brain / Antonio Reboreda -- Investigation of the possible role of TRP channels in schizophrenia / Loris A. Chahl -- Investigating diseases of dopaminergic neurons and melanocytes using zebrafish / Amanda Decker and Robert Cornell -- A practical guide to evaluating anxiety-related behavior in rodents / Caitlin J. Riebe and Carsten T. Wotjak -- Rodent models of conditioned fear: behavioral measures of fear and memory / Jennifer L. McGuire, Jennifer L. Coyner, and Luke R. Johnson -- Chick anxiety-depression screening model / Stephen W. White and Kenneth J. Sufka -- A clinically relevant thromboembolic stroke model in the aged rat / Ryan C. Turner, Alisa S. Elliott, Jason D. Huber, and Charles L. Rosen -- Use of cell-stretch system to examine the characteristics of mechanosensor channels: axonal growth/neuroregeneration studies / Koji Shibasaki -- Methods in neuronal growth cone biology / Robert J. Gasperini and Lisa Foa -- Transient receptor potential channels and pruritus / Heike Benecke, Janine Wäring, Tobias Lotts, and Sonja Ständer -- Skin sensitivity studies / Laurent Misery -- Hair follicle culture / Michael P. Philpott -- Animal models for type 1 diabetes / Anish Suri and Matteo Levisetti -- Type 2 diabetes models / Dorte X. Gram -- Using diet to induce metabolic disease in rodents / Angela M. Gajda, Michael A. Pellizzon, and Matthew R. Ricci -- Rodent models to evaluate anti-obesity drugs / Sharon C. Cheetham and Helen C. Jackson -- Experimental colitis models / Patrick A. Hughes, Stuart M. Brierley, Joel Castro, Andrea M. Harrington, and L. Ashley Blackshaw -- Tumor xenograft models to study the role of TRP channels in Tumorigenesis / V'yacheslav Lehen'kyi, Sergii Khalimonchyk, Albin Pourtier, Maylis Raphaël, and Natalia Prevarskaya -- Methods to study thermonociception in rodents / Kata Bölcskei -- Methods for the assessment of heat perception in humans / Michael F. Crutchlow and Joel D. Greenspan -- Collagen antibody-induced arthritis: a disease-relevant model for studies of persistent joint pain / Katalin Sandor, Kutty Selva Nandakumar, Rikard Holmdahl, and Camilla I. Svensson -- Animal models of muscular dystrophy / Yuko Iwata and Shigeo Wakabayashi -- Concluding remarks.
  • Mathematical modeling -- Gastrointestinal tract and skin -- Rheology -- Mass transport -- Drug dissolution and partitioning -- Dissolution of crystallites: size effectson on the solubility -- Drug release from matrix systems -- Drug release from microemulsions -- Drug permeation through membranes.
  • Virus-like particles in vaccine development / Franco M. Buonaguro & Luigi Buonaguro -- Developments in virus-like particle-based vaccines for HIV / Luigi Buonaguro, Maria Tagliamonte, Maria Luisa Visciano, Maria Lina Tornesello & Franco M Buonaguro -- Virus-like particle vaccines for the prevention of human papillomavirus infection / Joshua W. Wang, Richard B.S. Roden, Maria Lina Tornesello & Franco M. Buonaguro -- Virus-like particle-based vaccines against hepatitis C virus infection / Bertrand Bellier & David Klatzmann -- Evaluation of human rotavirus VLP vaccines in neonatal gnotobiotic pigs / Marli P. Azevedo, Anastasia N. Vlasova & Linda J. Saif -- Presenting heterologous epitopes with hepatitis B core-based virus-like particles / Sarah De Baets, Kenny Roose, Bert Schepens & Xavier Saelens -- SV40 virus-like particles as an effective delivery system and a vaccine platform / Masaaki Kawano, Masanori Matsui & Hiroshi Handa -- Plant-produced virus-like particle vaccines / Nunzia Scotti & Edward P. Rybicki -- Production of complex virus-like particles in insect cells / Fabiana Fernandes, Ana P. Teixeira, Nuno Carinhas, Manuel J.T. Carrondo & Paula M. Alves -- Index.
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