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- 2016 intravenous medications a handbook for nurses and health professionals. Thirty-second edition [32nd ed.]. — Instrumental data for drug analysis. 3rd ed. (100)
- Integrated drug discovery technologies — Understanding drug release and absorption mechanisms a physical and mathematical approach (100)
- Using the pharmaceutical literature — Write it down guidance for preparing effective and compliant documentation. 2nd ed. (5)
- Integrated drug discovery technologies 2002CRCnetBASE
- Intellectual property and health technologies balancing innovation and the public's health 2014SpringerIntroduction 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.
- Introduction to biological and small molecule drug research and development theory and case studies 2013ScienceDirectChapter 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.
- Isoquinolines and beta-carbolines as neurotoxins and neuroprotectants new vistas In Parkinson's disease therapy 2012Springer
- Law and ethics of the pharmaceutical industry 2006ScienceDirect
- Ligand-macromolecular interactions in drug discovery methods and protocols 2010Springer ProtocolsPart 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, 2007CRCnetBASEv. 2, 2007 CRCnetBASEv. 3, 2007 CRCnetBASEv. 1. Liposome preparation and related techniques -- v. 2. Entrapment of drugs and other materials into liposomes -- v. 3. Interactions of liposomes with the biological milieu.
- Patient Safety and Medication Administration -- Nursing Process Guidelines -- Pharmacologic Classes -- Alphabetical Listing of Drugs by Generic Name.
- Long acting injections and implants 2012Springer
- Mass spectrometry in drug discovery 2002CRCnetBASE
- Medicinal plants-- biodiversity and drugs 2012CRCnetBASENew 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.
- Meyler's Side effects of endocrine and metabolic drugs 2009ClinicalKeyCorticosteroids 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.
- Meyler's side effects of analgesics and anti-inflammatory drugs 2010ClinicalKeyElsevier 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.
- Meyler's Side effects of antimicrobial drugs 2010ClinicalKeyAntibacerial Drugs -- Antiviral Drugs, Including Immunoglobulins and Interferons -- Antifungal Drugs -- Antiprotozoal and Antihelminthic Drugs -- Vaccines -- Disinfectants and Antiseptics.
- Meyler's Side effects of cardiovascular drugs 2009ClinicalKeyElsevier 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.
- Meyler's Side effects of drugs used in cancer and immunology 2010ClinicalKeyDrugs Used in Cancer Chemotherpy -- Corticosteroids and Prostaglandins -- Cytokines and Cytokine Modulators Interferons -- Monoclonal Antibodies -- Immune Modulators.
- Meyler's Side effects of psychiatric drugs 2009ClinicalKeyAntidepressants -- Neuroleptic Drugs -- Hypnosedatives -- Drugs of Abuse -- Drugs use in Alzheimer's Disease -- Psychological and Psychiatric Adverse Effects of Non-Psychoactive Drugs.
- Microbial drug resistance 2013Future MedAntibiotic 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.
- Microdialysis in drug development 2013SpringerIn 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 as tools in biopharmaceutical production 2012Springer"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  of cover.
- Microspheres and microcapsules in biotechnology design, preparation, and applications 2013CRCnetBASE1. 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.
- Modern pharmaceutics. 4th ed., rev. and expanded. 2002CRCnetBASE
- Modified-release drug delivery technology 2003CRCnetBASE
- "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.
- Molecular pathomechanisms and new trends in drug research 2003CRCnetBASE
- Monte Carlo simulation for the pharmaceutical industry concepts, algorithms, and case studies 2011CRCnetBASE"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.
- Mosby's Dental drug reference. 11th edition. 2014ClinicalKeyIdeal 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.
- Multiple testing problems in pharmaceutical statistics 2010CRCnetBASE1. 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 2007CRCnetBASENanoparticulate 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.
- Novel antischizophrenia treatments 2012SpringerThis 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 2013SpringerOmics 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.
- Ophthalmologic drug guide. 2nd ed. 2011SpringerAntibacterial 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.
- Optimization in drug discovery in vitro methods. Second edition [2nd ed.] 2014Springer ProtocolsThoroughly 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.
- Parallel imports of pharmaceuticals evidence from Scandinavia and policy proposals from SWitzerland 2008Springer
- PAT applied in biopharmaceutical process development and manufacturing an enabling tool for quality-by-design 2012CRCnetBASE"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.
- Path from biomarker discovery to regulatory qualification 2013ScienceDirectThe 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.
- Pediatric formulations a roadmap 2014SpringerAs 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.
- Percutaneous penetration enhancers chemical methods in penetration enhancement drug manipulation strategies and vehicle effects 2015Springer
- Percutaneous penetration enhancers. 2nd ed. 2006CRCnetBASE
- Pharma's prescription how the right technology can save the pharmaceutical business 2014ScienceDirectThe 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.
- Pharmaceutical biotechnology. 2nd ed. 2006CRCnetBASE
- 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.
- Pharmaceutical dissolution testing 2005CRCnetBASE
- 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.
- Pharmaceutical isothermal calorimetry 2007CRCnetBASE
- Pharmaceutical photostability and stabilization technology 2006CRCnetBASE
- Pharmaceutical process scale-up. 2nd ed. 2006CRCnetBASE
- 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.
- Pharmaceutical regulatory process 2005CRCnetBASE
- Contains proceedings of the AAPS Stability Workshop.
- Pharmaceutical statistics using SAS-- a practical guidebooks24x7, SUNet ID login required.2007 ProQuest SafariStatistics 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.
- Pharmaceutical stress testing predicting drug degradation 2005CRCnetBASE
- 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.
- Pharmacogenomic testing in current clinical practice implementation in the clinical laboratory 2011Springer
- Pharmacogenomics. 2nd ed. 2005CRCnetBASEHistorical 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 --
- Pharmacological basis of acute care 2015SpringerThis 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. 2013ClinicalKeyPharmacology, 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 www.studentconsult.com, 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 law and practice. 4th ed. 2006ScienceDirect
- Pharmacy practice research methods 2015SpringerPharmacy 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 2014SpringerDue 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.
- Polymers in drug delivery 2006CRCnetBASE
- Practical pharmaceutics an international guideline for the preparation, care and use of medicinal products 2015SpringerPreface -- 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.
- Preclinical drug development 2005CRCnetBASE
- Principles of electronic prescribing. 2nd ed. 2012SpringerPhilosophical 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.
- Principles of safety pharmacology 2015Springer
- Process of new drug discovery and development. 2nd ed. 2006CRCnetBASEOverview 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.
- Process validation in manufacturing of biopharmaceuticals guidelines, current practices, and industrial case studies 2005CRCnetBASE
- Radiotracers in drug development 2006CRCnetBASERadiotracers 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.
- Real world drug discovery a chemist's guide to biotech and pharmaceutical research. 1st ed. 2008ScienceDirectThe 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.
- Six sigma in the pharmaceutical industry understanding, reducing, and controlling variation in pharmaceuticals and biologics 2007CRCnetBASEThe 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.
- Smith and Williams' Introduction to the principles of drug design and action. 4th ed. 2006CRCnetBASE
- Spectroscopy of pharmaceutical solids 2006CRCnetBASE
- Statistical design and analysis of stability studies 2007CRCnetBASEIntroduction -- 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.
- Sterile product development formulation, process, quality and regulatory considerations 2013SpringerThis 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.
- Synthesis of essential drugs 2006ScienceDirect
- 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.
- Theory and practice of contemporary pharmaceutics 2005CRCnetBASEMethods 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.].
- Theory of drug development 2014CRCnetBASESection I. A theory of evaluating drugs -- section II. A theory of evidence in drug development -- section III. Additional topics.
- Therapeutic drug monitoring newer drugs and biomarkers 2012ScienceDirect2012 ClinicalKeyTherapeutic 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.
- Toxicologic pathology-- nonclinical safety assessment 2013CRCnetBASEOverview 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.
- Translational medicine-- the future of therapy? 2013CRCnetBASEChapter 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 discovery, optimization, clinical study and regulation 2013SpringerTransporters 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=, 2012Springer Protocols2nd ed., 2014 Springer ProtocolsV. 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.
- Understanding drug release and absorption mechanisms a physical and mathematical approach 2007CRCnetBASEMathematical 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.
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