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Statistical Issues in Drug Research and Development

2017-09-19 Mathematics
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Release : 2017-09-19
Genre : Mathematics
Kind : eBook
Book Rating : 437/5 ( reviews)

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Book Synopsis Statistical Issues in Drug Research and Development by : Karl E. Peace

Download or read book Statistical Issues in Drug Research and Development written by Karl E. Peace. This book was released on 2017-09-19. Available in PDF, EPUB and Kindle. Book excerpt: This book is a compilation of topics addressed by the ASA Biopharmaceutical Section work groups, including the etiology and evolution of the work groups, the work group guidelines and structure, and the statistical issues associated with clinical trials in clinical drug development programs.

Statistical Issues in Drug Development

2021-08-23 Medical
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Release : 2021-08-23
Genre : Medical
Kind : eBook
Book Rating : 579/5 ( reviews)

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Book Synopsis Statistical Issues in Drug Development by : Stephen S. Senn

Download or read book Statistical Issues in Drug Development written by Stephen S. Senn. This book was released on 2021-08-23. Available in PDF, EPUB and Kindle. Book excerpt: Statistical Issues in Drug Development The revised third edition of Statistical Issues in Drug Development delivers an insightful treatment of the intersection between statistics and the life sciences. The book offers readers new discussions of crucial topics, including cluster randomization, historical controls, responder analysis, studies in children, post-hoc tests, estimands, publication bias, the replication crisis, and many more. This work presents the major statistical issues in drug development in a way that is accessible and comprehensible to life scientists working in the field, and takes pains not to gloss over significant disagreements in the field of statistics, while encouraging communication between the statistical and life sciences disciplines. In addition to new material on topics like invalid inversion, severity, random effects in network meta-analysis, and explained variation, readers will benefit from the inclusion of: A thorough introduction to basic topics in drug development and statistics, including the role played by statistics in drug development An exploration of the four views of statistics in drug development, including the historical, methodological, technical, and professional An examination of debatable and controversial topics in drug development, including the allocation of treatments to patients in clinical trials, baselines and covariate information, and the measurement of treatment effects Perfect for life scientists and other professionals working in the field of drug development, Statistical Issues in Drug Development is the ideal resource for anyone seeking a one-stop reference to enhance their understanding of the use of statistics during drug development.

Statistical Issues in Drug Development

2008-02-28 Medical
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Release : 2008-02-28
Genre : Medical
Kind : eBook
Book Rating : 579/5 ( reviews)

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Book Synopsis Statistical Issues in Drug Development by : Stephen S. Senn

Download or read book Statistical Issues in Drug Development written by Stephen S. Senn. This book was released on 2008-02-28. Available in PDF, EPUB and Kindle. Book excerpt: Drug development is the process of finding and producingtherapeutically useful pharmaceuticals, turning them into safe andeffective medicine, and producing reliable information regardingthe appropriate dosage and dosing intervals. With regulatoryauthorities demanding increasingly higher standards in suchdevelopments, statistics has become an intrinsic and criticalelement in the design and conduct of drug development programmes. Statistical Issues in Drug Development presents anessential and thought provoking guide to the statistical issues andcontroversies involved in drug development. This highly readable second edition has been updated toinclude: Comprehensive coverage of the design and interpretation ofclinical trials. Expanded sections on missing data, equivalence, meta-analysisand dose finding. An examination of both Bayesian and frequentist methods. A new chapter on pharmacogenomics and expanded coverage ofpharmaco-epidemiology and pharmaco-economics. Coverage of the ICH guidelines, in particular ICH E9,Statistical Principles for Clinical Trials. It is hoped that the book will stimulate dialogue betweenstatisticians and life scientists working within the pharmaceuticalindustry. The accessible and wide-ranging coverage make itessential reading for both statisticians and non-statisticiansworking in the pharmaceutical industry, regulatory bodies andmedical research institutes. There is also much to benefitundergraduate and postgraduate students whose courses include amedical statistics component.

Interface between Regulation and Statistics in Drug Development

2020-11-11 Mathematics
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Release : 2020-11-11
Genre : Mathematics
Kind : eBook
Book Rating : 709/5 ( reviews)

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Book Synopsis Interface between Regulation and Statistics in Drug Development by : Demissie Alemayehu

Download or read book Interface between Regulation and Statistics in Drug Development written by Demissie Alemayehu. This book was released on 2020-11-11. Available in PDF, EPUB and Kindle. Book excerpt: With the critical role of statistics in the design, conduct, analysis and reporting of clinical trials or observational studies intended for regulatory purposes, numerous guidelines have been issued by regulatory authorities around the world focusing on statistical issues related to drug development. However, the available literature on this important topic is sporadic, and often not readily accessible to drug developers or regulatory personnel. This book provides a systematic exposition of the interplay between the two disciplines, including emerging themes pertaining to the acceleration of the development of pharmaceutical medicines to serve patients with unmet needs. Features: Regulatory and statistical interactions throughout the drug development continuum The critical role of the statistician in relation to the changing regulatory and healthcare landscapes Statistical issues that commonly arise in the course of drug development and regulatory interactions Trending topics in drug development, with emphasis on current regulatory thinking and the associated challenges and opportunities The book is designed to be accessible to readers with an intermediate knowledge of statistics, and can be a useful resource to statisticians, medical researchers, and regulatory personnel in drug development, as well as graduate students in the health sciences. The authors’ decades of experience in the pharmaceutical industry and academia, and extensive regulatory experience, comes through in the many examples throughout the book.

Statistical issues in pharmaceutical industry

1990
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Release : 1990
Genre :
Kind : eBook
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Book Synopsis Statistical issues in pharmaceutical industry by : Gary G. Koch

Download or read book Statistical issues in pharmaceutical industry written by Gary G. Koch. This book was released on 1990. Available in PDF, EPUB and Kindle. Book excerpt:

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