Books by Subject
- 2008 OvidAmy M. Karch.
- 2011 OvidAmy M. Karch.
- 2007 OvidAmy M. Karch.
- 2015 OvidAmy M. Karch.Patient Safety and Medication Administration -- Nursing Process Guidelines -- Pharmacologic Classes -- Alphabetical Listing of Drugs by Generic Name.
- 2012 OvidAmy M. Karch.
- 2012 SpringerJeremy C. Wright, Diane J. Burgess, editors.
- 2016 Springer[edited by] Maureen Mackintosh, Geoffrey Banda, Paula Tibandebage, Watu Wamae.Making medicines in Africa : an historical political economy overview / Geoffrey Banda, Samuel Wangwe, Maureen Mackintosh -- Pharmaceuticals in Kenya : the evolution of technological capabilities / Roberto Simonetti, Norman Clark -- Pharmaceutical manufacturing decline in Tanzania : how possible is a turnaround to growth? / Paula Tibandebage, Samuel Wangwe, Maureen Mackintosh -- Bringing industrial and health policies closer : reviving pharmaceutical production in Ethiopia / Tsige Gebre-Mariam, Kedir Tahir, Solomon Gebre-Amanuel -- South-south collaboration in pharmaceuticals : manufacturing antiretroviral medicines in Mozambique / Giuliano Russo, Lâicia de Oliveira -- Can foreign firms promote local production of pharmaceuticals in Africa? / Sudip Chaudhuri -- Raising the technological level : the scope for API, excipients, additives and biologicals manufacture in Africa / Joseph Fortunak, Skhumbuzo Ngozwana, Tsige Gebre-Mariam, Tiffany Ellison, Paul Watts -- Health systems as industrial policy : building collaborative capabilities in the Tanzanian and Kenyan health sectors and their local suppliers / Maureen Mackintosh, Paula Tibandebage, Joan Kariuki Kungu, Mercy Karimi Njeru, Caroline Israel -- The dissemination of local health innovations : political economy issues in Brazil / Erika Aragäao, Jane Mary Guimaräaes, Sebastiäao Loureiro -- Healthy industries and unhealthy populations : lessons from Indian problem-solving / Smita Srinivas -- Policies to control medicines prices : does the South African experience have lessons for other African countries? / Skhumbuzo Ngozwana -- African pharmaceutical standards : the road to improvement and their role in technological capability upgrading / Geoffrey Banda, Julius Mugwagwa, Dinar Kale, Margareth Ndomondo-Sigonda -- Innovative procurement for health and industrial development / Joanna Chataway, Geoffrey Banda, Gavin Cochrane and Catriona Manville -- Industry associations and the changing politics of making medicines in South Africa / Theo Papaioannou, Andrew Watkins, Julius Mugwagwa, Dinar Kale -- Finance and incentives to support the development of national pharmaceutical industries / Alastair West, Geoffrey Banda.
- 2012 Wileyedited by Mark Wigglesworth and Terry Wood.
- 2008 Wileyby John J. Tobin and Gary Walsh.
- 2005 MyiLibraryThomas Nogrady, Donald F. Weaver.Also available: Print – 2005
- 2012 CRCnetBASEeditors, Mahendra Rai, Geofffrey A. Cordell, Jose L. Martinez, Mariela Marinoff, Luca Rastrelli.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.
- 2006 CambridgeSoftMaryadele J. O'Neil, editor ... [et al.].Also available: Print – 2006
- 2013Maryadele J. O'Neil, editor-in-chief ; Patricia E. Heckelman, senior associate editor ; Peter H. Dobbelaar, associate editor ; Kristin J. Roman, assistant editor ; Catherine M. Kenny, senior editorial assistant ; Linda S. Karaffa, technical assistant.
- 2009 ClinicalKeyeditor, J.K. Aronson.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.
- 2010 ClinicalKeyeditor J.K. Aronson.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.
- 2010 ClinicalKeyedited by Jeffrey K. Aronson.Antibacerial Drugs -- Antiviral Drugs, Including Immunoglobulins and Interferons -- Antifungal Drugs -- Antiprotozoal and Antihelminthic Drugs -- Vaccines -- Disinfectants and Antiseptics.
- 2009 ClinicalKeyeditor, J.K. Aronson.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.
- 2009 ClinicalKeyeditor, J.K. Aronson.Antidepressants -- Neuroleptic Drugs -- Hypnosedatives -- Drugs of Abuse -- Drugs use in Alzheimer's Disease -- Psychological and Psychiatric Adverse Effects of Non-Psychoactive Drugs.
- 2013 Future Mededitor, Vladimir Krcméry.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.
- 2013 SpringerMarkus Müller, editor.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.
- 2012 SpringerNiall Barron, editor."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.
- 2013 CRCnetBASEGuanghui Ma, Zhiguo Su.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.
- 2012 CRCnetBASEedited by Beena Rai."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.
- 2011 CRCnetBASEMark Chang."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.
- 2014 ClinicalKeyArthur H. Jeske [editor].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.
- 2010 CRCnetBASEedited by Alex Dmitrienko, Ajit C. Tamhane, Frank Bretz.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.].
- 2007 CRCnetBASEedited by Deepak Thassu, Michel Deleers, Yashwant Pathak.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.
- 2016 SpringerUlrich Nielsch, Ulrike Fuhrmann, Stefan Jaroch, editors.This volume gives an overview of state of the art technologies and future developments in the field of preclinical pharmaceutical research. A balanced mix of experts from academia and industry give insight in selected new developments in the drug discovery pathway. The topics cover the different parts of the drug discovery process, starting with new developments in the target identification and validation area. The lead generation part as a next step focuses on the requirements and technologies to identify new small molecules as lead compounds for further optimization; in a second section the technologies to identify biologics as leads are addressed. The final part focuses on the pharmacological models and technologies to characterize new compounds and the impact of biomarkers to facilitate the transfer of drug candidates into the development phase.
- 2013 Wileyedited by William J. Brock, Kenneth L. Hastings, and Kathy McGown.Introduction to the development of drugs / Kathy McGown -- ICH / Ken Hastings -- USFDA / Bill Brock -- Latin America : MERCOSUR countries / Cristiana Leslie Corra -- Canada / Mark T. Goldberg -- EMEA / Adam Woolley -- Africa / Fariza Feraoun -- China / Lijie Fu -- Japan / Kazuichi Nakamura -- India / K.S. Rao -- Australia / Doug Francis -- Chronic repeat dose testing / Shana Azri-Meehan -- Carcinogenicity / James Popp -- Genotoxicity / Mark Powley -- Developmental and reproductive toxicology / Robert Parker -- Juvenile testing and pediatric claim / Melissa Tassinari -- Immunotoxicology / Leigh Ann Burns Naas -- Biologics / Chris Ellis -- Vaccines / Robert House -- Phototoxicity and photocarcinogenicity / Chris Sambuco -- Degradants, impurities excipients, and metabolites / Bob Osterberg.
- 2012 SpringerMark A. Geyer, Gerhard Gross, editors.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.
- 2013 SpringerDebmalya Barh, Dipali Dhawan, Nirmal Kumar Ganguly, editors.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.
- 2011 SpringerDouglas J. Rhee, Kathryn A. Colby, Lucia Sobrin, Christopher J. Rapuano.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.
- 2014 Springer Protocolsedited by Gary W. Caldwell and Zhengyin Yan, CREATe Analytical Sciences, Janssen Research & Development, LLS, Spring House, PA, USA.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.
- 2013Alisha Rankin."Panaceia's Daughters provides the first book-length study of noblewomen's healing activities in early modern Europe. Drawing on rich archival sources, Alisha Rankin demonstrates that numerous German noblewomen were deeply involved in making medicines and recommending them to patients, and many gained widespread fame for their remedies. Turning a common historical argument on its head, Rankin maintains that noblewomen's pharmacy came to prominence not in spite of their gender but because of it. Rankin demonstrates the ways in which noblewomen's pharmacy was bound up in notions of charity, class, religion, and household roles, as well as in expanding networks of knowledge and early forms of scientific experimentation. The opening chapters place noblewomen's healing within the context of cultural exchange, experiential knowledge, and the widespread search for medicinal recipes in early modern Europe. Case studies of renowned healers Dorothea of Mansfeld and Anna of Saxony then demonstrate the value their pharmacy held in their respective roles as elderly widow and royal consort, while a study of the long-suffering Duchess Elisabeth of Rochlitz emphasizes the importance of experiential knowledge and medicinal remedies to the patient's experience of illness." --Publisher's description.
- Parallel imports of pharmaceuticals : evidence from Scandinavia and policy proposals from SWitzerland2008 Springerby Cédric Julien Poget.
- PAT applied in biopharmaceutical process development and manufacturing : an enabling tool for quality-by-design2012 CRCnetBASEedited by Cenk Undey, Duncan Low, Jose C. Menezes, Mel Koch."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.
- 2013 ScienceDirectFederico Goodsaid, William B. Mattes.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.
- 2014 SpringerDaniel Bar-Shalom, Klaus Rose, editors.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.
- 2005 CRCnetBASEedited by Robert L. Bronaugh, Howard I. Maibach.Also available: Print – 2005
- Percutaneous penetration enhancers chemical methods in penetration enhancement. drug manipulation strategies and vehicle effects2015 SpringerNina Dragicevic, Howard I. Maibach, editors.
- Pharmaceutical accumulation in the environment : prevention, control, health effects, and economic impact2014 CRCnetBASEedited by Walter E. Goldstein.1. Introduction / Walter E. Goldstein -- 2. An insight into the discovery of the contamination of the environment and drinking water by pharmaceuticals / Thomas Heberer -- 3. Presence and fate of pharmaceuticals in the environment and in drinking water / James S. Smith Jr. -- 4. Occurrence, effects, and methods for antibiotics and illicit drugs in the environment / Tammy Jones-Lepp -- 5. Detection of pharmaceuticals in the environment : history of use as a forensic tool / Keir Soderberg and Remy J.-C. Hennet -- 6. Health impact of pharmaceuticals in the environment and in drinking water : potential for human and environmental risk / James S. Smith Jr. -- 7. Health impact of pharmaceuticals in the environment and in drinking water : analysis and research needs / Walter E. Goldstein -- 8. Effect of antibiotics on biological wastewater treatment processes / Olivier Potier, Jean-Noël Louvet, Christophe Merlin, Marie-Noëlle Pons, Dominique Dumas, and Walter E. Goldstein -- 9. Wastewater pharmaceuticals minimization : analysis of opportunities and costs / Walter E. Goldstein -- 10. Conclusions and recommendations, research opportunities, and implementation of measures to control environmental pharmaceuticals / Walter E. Goldstein.
- 2006 CRCnetBASEedited by Michael J. Groves.
- 2012 SpringerRaymond A. Huml.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.
- 2007 CRCnetBASESimon Gaisford, Michael A.A. O'Neill.
- 2008 ebrary2008 CRCnetBASEedited by Tony Kennedy.Strategic project management at the project level / Tony Kennedy -- Strategic project management at the portfolio level / Kevin Bilyard and Des Markland -- Project planning : from basic concepts to systems application / Carl A. Kutzbach, Carole Strong, and Sylvia Walker -- Project management of chemical, analytical, and formulation development / Dieter Krimmer -- Project management in exclusive synthesis / Lukas M.J. von Hippel -- Clinical trials--can they be project managed? / Les Rose -- Regulatory project management / Nicholas Wells -- Teams / Ralph White -- Project management and outsourcing drug development / Jon Court and Mark Fowler -- The project management function / Tony Kennedy.Also available: Print – 2008
- 2015 SpringerReem K. Al-Essa, Mohammed Al-Rubaie, Stuart Walker, Sam Salek.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.
- 2010 Springeredited by Kim Huynh-Ba.Contains proceedings of the AAPS Stability Workshop.
- 2007 ProQuest Safari[edited by] Alex Dmitrienko, Christy Chuang-Stein, Ralph D'Agostino.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.
- 2011 SpringerAnthony J. Hickey, Hugh D.C. Smyth.
- 2014 SpringerBrian R. Moyer, Narayan P.S. Cheruvu, Tom C.-C. Hu, editors.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.
- 2011 SpringerAlan H.B. Wu, Kiang-Teck J. Yeo, editors.
- 2013 Springer Protocolsedited by Federico Innocenti, Ron H.N. van Schaik.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.
- 2015 SpringerYoo Keun Chan, Kwee Peng Ng, Debra Si Mui Sim, editors.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.
- 2014 SpringerPablo Avanzas, Peter Clemmensen, editors.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.
- 2013 ClinicalKeyGeorge M. Brenner, Craig W. Stevens.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 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.
- 2006 ScienceDirectJonathan Merrills and Jonathan Fisher.
- 2015 SpringerZaheer-Ud-Din Babar, editor.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.
- 2014 ScienceDirectKamal Biswas.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.
- 2014 SpringerFabrizio Benedetti, Paul Enck, Elisa Frisaldi, Manfred Schedlowski, editors.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.
- Practical pharmaceutics : an international guideline for the preparation, care and use of medicinal products2015 SpringerYvonne Bouwman-Boer, V'lain Fenton-May, Paul Le Brun, editors.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.
- edited by Jeremy A. Greene and Elizabeth Siegel Watkins.Goofball panic : barbiturates, "dangerous" and addictive drugs, and the regulation of medicine in postwar America / Nicolas Rasmussen -- Pharmacological restraints : antibiotic prescribing and the limits of physician autonomy / Scott H. Podolsky -- "Eroding the physician's control of therapy" : the post-war politics of the prescription / Dominique A. Tobbell -- Deciphering the prescription : pharmacists and the patient package insert / Elizabeth Siegel Watkins -- The Right to write : prescription and nurse practitioners / Julie A. Fairman -- The Best prescription for women's health : feminist approaches to well-woman care / Judith A. Houck -- "Safer than aspirin" : the campaign for over-the-counter oral contraceptives and emergency contraceptive pills / Heather Munro Prescott -- The Prescription as stigma : opioid pain relievers and the long walk to the pharmacy counter / Marcia L. Meldrum -- Busted for blockbusters : "scrip mills," quaalude, and prescribing power in the 1970s / David Herzberg -- The Afterlife of the prescription : the sciences of therapeutic surveillance / Jeremy A. Greene.
- 2012 SpringerStephen Goundrey-Smith.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.
- 2015 SpringerMichael K. Pugsley, Michael J. Curtis, editors.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.
- 2007 CRCnetBASEedited by Abhinav A. Shukla, Mark R. Etzel, Shishir Gadam.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.
- Quality assurance of pharmaceuticals : WHO guidelines, good practices, related guidance and GXP training materials.. Version 5.0.2015
- Quality assurance of pharmaceuticals : WHO guidelines, good practices, related regulatory guidance and GXP training materials.. Version 6.0.2016
- Quality assurance of pharmaceuticals : WHO guidelines, related guidance and GXP training materials, 20142014World Health Organization.
- 2008 ScienceDirectRobert M. Rydzewski.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.
- 2013 SpringerLarry K. Golightly, Isaac Teitelbaum, Tyree H. Kiser, Dimitriy A. Levin, Gerard R. Barber, Michael A. Jones, Nancy M. Stolpman, Katherine S. Lundin, editors.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.
- 2011 SpringerEdward D. Zanders.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.
- 2011 SpringerVitomir Šunjić, Michael J. Parnham.
- Six sigma in the pharmaceutical industry : understanding, reducing, and controlling variation in pharmaceuticals and biologics2007 CRCnetBASEBrian K. Nunnally, John S. McConnell.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.
- 2006 CRCnetBASEedited by H. John Smith.
- 2007 CRCnetBASEShein-Chung Chow.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.
- 2013 SpringerParag Kolhe, Mrinal Shah, Nitin Rathore, editors.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.
- 2015 Knoveledited by Marcos Luciano Bruschi.
- 2013 Future MedThomas Bieber.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.
- 2014 CRCnetBASEedited by Gregory K. Webster.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.
- 2006 ScienceDirectR.S. Vardanyan, V.J. Hruby.
- 2012 SpringerAsfar S. Azmi, editor.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.
- 2014 CRCnetBASEEric B. Holmgren.Section I. A theory of evaluating drugs -- section II. A theory of evidence in drug development -- section III. Additional topics.
- 2012 ScienceDirect2012 ClinicalKeyedited by Amitava Dasgupta.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.
- 2016 SpringerByong-Hyon Han.Preface -- Chapter 1: Why Social Medicine? -- 1.1: The Rise of Social Medicine -- 1.2: Human-being: Homo medicus -- 1.3: History of Drug -- Chapter 2: What is a Social Medicine? -- 2.1: Concept of Social Medicine -- 2.2: Development of Social Medicine -- 2.3: Differentiation of Social Medicine -- Chapter 3: Therapy of Social Medicine -- 3.1: Concept & Scope for Therapy of Social Medicine -- 3.2: Classification for Therapy of Social Medicine -- Chapter 4: Pharmaco-gelotology -- 4.1: Introduction -- 4.2: Laughter Theory -- 4.3: Laughter Therapy -- Chapter 5: Conclusion.
- 2013 CRCnetBASEedited by Pritam S. Sahota, James A. Popp, Jerry F. Hardisty, and Chirukandath Gopinath.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.
- 2013 CRCnetBASEedited by James Mittra, Christopher-Paul Milne.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.
- 2013 SpringerYuichi Sugiyama, Bente Steffansen, editors.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.
- v.1-2=, 2012 Springer Protocols2nd ed., 2014 Springer Protocolsedited by Arpad Szallasi, Tamás Bíró.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.
- 2007 CRCnetBASEMario Grassi ... [et al.].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.
- 2014 Future Mededitors, Franco M. Buonaguro, Luigi Buonaguro.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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Includes cited reference searching, citation maps, and an analyze tool.
Features systematic reviews that summarize the effects of interventions and makes a determination whether the intervention is efficacious or not.
Cochrane reviews are created through a strict process of compiling and analyzing data from multiple randomized control trials to ensure comprehensiveness and reliability.Provides systematic coverage of the psychological literature from the 1800s to the present through articles, book chapters and dissertations.BMJ Clinical Evidence. A clinical information tool built around systematic reviews summarizing the current state of knowledge about prevention and treatment of clinical conditions.PIER (Physicians' Information and Education Resource) is a Web-based decision-support tool designed for rapid point-of-care delivery of up-to-date, evidence-based guidance for primary care physicians.Cochrane Central Register of Controlled Trials (CENTRAL) provides access to 300,000 controlled trials that have been identified the Cochrane Collaboration.Provides drug information targeted for patients.A continually updating drug monograph.The National Guideline Clearinghouse (NGC): A comprehensive database of evidence-based clinical practice guidelines and related documents.MedlinePlus: A repository of health information from the National Library of Medicine. Links are from trusted sites. No advertising, no endorsement of commercial companies or productsLPCH CareNotes via MicroMedex: Patient education handouts customized by LPCH clinical staffMicromedex Lab Advisor: Evidence based laboratory test informationA drug database organized by generic name, trade name and drug class.LPCH / Stanford Hospital Formulary.A goldmine of trusted consumer health information from the world's largest medical library.A trusted source of expert advice for and about kids, providing the information necessary to help patients and parents understand their unique needs.Provides patient handouts from the American Academy of Family Physician.Access to the Stanford Health Library for patients.Lane provides access to over 5,000 eBooks many of which provide helpful background material that will prepare you to better tackle primary literature.
Largest, broadest eBook package; covers all sciences, as well as technology (including software), medicine, and humanities.
In addition to covering Wiley and Springer, MyiLibrary is also the only provider for Oxford and Cambridge University Press titles. No seat restrictions.A collection of biomedical books that can be searched directly by concept, and linked to terms in PubMed abstracts.
A web-based, decision support system for infectious diseases, epidemiology, microbiology and antimicrobial chemotherapy. The database, updated weekly, currently includes 337 diseases, 224 countries, 1,147 microbial taxa and 306 antibacterial (-fungal, -parasitic, -viral) agents and vaccines.
Over 10,000 notes outline the status of specific infections within each country.
Provides online, full-text access to Springer's journal titles as well as journals from other publishers.
Subjects include: life sciences, chemical sciences, environmental sciences, geosciences, computer science, mathematics, medicine, physics and astronomy, engineering and economics. Also includes eBooks.Collection of over 8 thousand fulltext titles in engineering, math, and basic and applied biomedical research. Coverage is from 1967 to the present.A library of ebooks on a wide array of topics, digitized and made available online in conjunction with the original publishers.