(Izdošanas datums: 07-Mar-2024, PDF+DRM, Izdevniecība: Taylor & Francis Ltd, ISBN-13: 9781003848066)
The present volume, Life Sciences Research to Product Development: Regulatory Requirement Transforming, Volume 1, discusses the procedures of drug approval and regulatory requirements that must be met according to the United States Food and Drug Admi...Lasīt vairāk
(Izdošanas datums: 07-Mar-2024, EPUB+DRM, Izdevniecība: Taylor & Francis Ltd, ISBN-13: 9781003848097)
The present volume, Life Sciences Research to Product Development: Regulatory Requirement Transforming, Volume 1, discusses the procedures of drug approval and regulatory requirements that must be met according to the United States Food and Drug Admi...Lasīt vairāk
(Izdošanas datums: 01-Aug-2017, EPUB+DRM, Izdevniecība: John Wiley & Sons Inc, ISBN-13: 9781119425014)
A comprehensive introduction for scientists engaged in new drug development, analysis, and approvals Each year the pharmaceutical industry worldwide recruits thousands of recent science graduates especially chemistry, analytical chemistry, pharmacy,...Lasīt vairāk
(Izdošanas datums: 12-Jul-2017, PDF+DRM, Izdevniecība: John Wiley & Sons Inc, ISBN-13: 9781119425038)
A comprehensive introduction for scientists engaged in new drug development, analysis, and approvals Each year the pharmaceutical industry worldwide recruits thousands of recent science graduates especially chemistry, analytical chemistry, pharmacy,...Lasīt vairāk
(Izdošanas datums: 28-Apr-2015, EPUB+DRM, Izdevniecība: John Wiley and Sons Ltd, ISBN-13: 9781118907191)
The third edition of this best-selling book continues to offer a user-friendly, step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of pre-clinical studies, the conduct of human clin...Lasīt vairāk
(Izdošanas datums: 13-Apr-2015, PDF+DRM, Izdevniecība: John Wiley and Sons Ltd, ISBN-13: 9781118907221)
The third edition of this best-selling book continues to offer a user-friendly, step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of pre-clinical studies, the conduct of human clin...Lasīt vairāk
(Izdošanas datums: 23-Oct-2014, PDF+DRM, Izdevniecība: John Wiley & Sons Inc, ISBN-13: 9781118470992)
Statistical Thinking for Non-Statisticians in Drug Regulation, Second Edition, is a need-to-know guide to understanding statistical methodology, statistical data and results within drug development and clinical trials.It provides non-statisticians wo...Lasīt vairāk
(Izdošanas datums: 23-Oct-2014, EPUB+DRM, Izdevniecība: John Wiley & Sons Inc, ISBN-13: 9781118470978)
Statistical Thinking for Non-Statisticians in Drug Regulation, Second Edition, is a need-to-know guide to understanding statistical methodology, statistical data and results within drug development and clinical trials.It provides non-statisticians wo...Lasīt vairāk
Clinical research is heavily regulated and involves coordination of numerous pharmaceutical-related disciplines. Each individual trial involves contractual, regulatory, and ethics approval at each site and in each country. Clinical trials have become...Lasīt vairāk
Institute of Medicine, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation, Tracy A. Lustig, Victoria Weisfeld
(Izdošanas datums: 24-Oct-2013, EPUB+DRM, Izdevniecība: National Academies Press, ISBN-13: 9780309284820)
The past several decades have been a time of rapid globalization in the development, manufacture, marketing, and distribution of medical products and technologies. Increasingly, research on the safety and effectiveness of new drugs is being conducted...Lasīt vairāk
Institute of Medicine, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation, Tracy A. Lustig, Victoria Weisfeld
(Izdošanas datums: 24-Oct-2013, PDF+DRM, Izdevniecība: National Academies Press, ISBN-13: 9780309284806)
The past several decades have been a time of rapid globalization in the development, manufacture, marketing, and distribution of medical products and technologies. Increasingly, research on the safety and effectiveness of new drugs is being conducted...Lasīt vairāk
William J. Brock, Kenneth L. Hastings, Kathy M. McGown
(Izdošanas datums: 05-Mar-2013, EPUB+DRM, Izdevniecība: John Wiley & Sons Inc, ISBN-13: 9781118516980)
Nonclinical Safety Assessment Nonclinical Safety Assessment A Guide to International Pharmaceutical Regulations Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty...Lasīt vairāk
William J. Brock, Kenneth L. Hastings, Kathy M. McGown
(Izdošanas datums: 20-Feb-2013, PDF+DRM, Izdevniecība: John Wiley & Sons Inc, ISBN-13: 9781118517017)
Nonclinical Safety Assessment Nonclinical Safety Assessment A Guide to International Pharmaceutical Regulations Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty...Lasīt vairāk
Institute of Medicine, Board on Population Health and Public Health Practice, Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs
(Izdošanas datums: 30-Jul-2012, PDF+DRM, Izdevniecība: National Academies Press, ISBN-13: 9780309218146)
An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious an...Lasīt vairāk
Institute of Medicine, Board on Population Health and Public Health Practice, Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs
(Izdošanas datums: 30-Jul-2012, EPUB+DRM, Izdevniecība: National Academies Press, ISBN-13: 9780309218160)
An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious an...Lasīt vairāk
(Izdošanas datums: 17-Apr-2012, PDF+DRM, Izdevniecība: John Wiley & Sons Inc, ISBN-13: 9781118266793)
A comprehensive guide to optimizing the lifecycle management of pharmaceutical brands The mounting challenges posed by cost containment policies and the prevalence of generic alternatives make optimizing the lifecycle management (LCM) of brand drugs...Lasīt vairāk
(Izdošanas datums: 16-Apr-2012, EPUB+DRM, Izdevniecība: John Wiley & Sons Inc, ISBN-13: 9781118265895)
A comprehensive guide to optimizing the lifecycle management of pharmaceutical brands The mounting challenges posed by cost containment policies and the prevalence of generic alternatives make optimizing the lifecycle management (LCM) of brand drugs...Lasīt vairāk
(Izdošanas datums: 25-Feb-2011, EPUB+DRM, Izdevniecība: John Wiley & Sons Inc, ISBN-13: 9781118035207)
The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing a...Lasīt vairāk
(Izdošanas datums: 03-Aug-2010, PDF+DRM, Izdevniecība: John Wiley & Sons Inc, ISBN-13: 9780470613177)
The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing a...Lasīt vairāk
(Izdošanas datums: 20-Jul-2010, EPUB+DRM, Izdevniecība: Taylor & Francis Inc, ISBN-13: 9781040170700)
Now viewed as its own scientific discipline, clinical trial methodology encompasses the methods required for the protection of participants in a clinical trial and the methods necessary to provide a valid inference about the objective of the trial. D...Lasīt vairāk
