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Item Details
Title: STATISTICAL ISSUES IN DRUG DEVELOPMENT
By: Stephen S. Senn
Format: Hardback

List price: £98.25


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ISBN 10: 0470018771
ISBN 13: 9780470018774
Publisher: JOHN WILEY AND SONS LTD
Pub. date: 1 January, 2008
Edition: 2nd Revised edition
Series: Statistics in Practice
Pages: 524
Description: There are many books on medical statistics that explain to the physician how to calculate various common statistics and how to perform various tests. Many of them present a simplified and distorted view of statistics, which gives no impression of the philosophical difficulties that the science has to confront.
Synopsis: Drug development is the process of finding and producing therapeutically useful pharmaceuticals, turning them into safe and effective medicine, and producing reliable information regarding the appropriate dosage and dosing intervals. With regulatory authorities demanding increasingly higher standards in such developments, statistics has become an intrinsic and critical element in the design and conduct of drug development programmes. Statistical Issues in Drug Development presents an essential and thought provoking guide to the statistical issues and controversies involved in drug development. This highly readable second edition has been updated to include:* Comprehensive coverage of the design and interpretation of clinical trials.* Expanded sections on missing data, equivalence, meta-analysis and dose finding.* An examination of both Bayesian and frequentist methods.* A new chapter on pharmacogenomics and expanded coverage of pharmaco-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 between statisticians and life scientists working within the pharmaceutical industry. The accessible and wide-ranging coverage make it essential reading for both statisticians and non-statisticians working in the pharmaceutical industry, regulatory bodies and medical research institutes. There is also much to benefit undergraduate and postgraduate students whose courses include a medical statistics component.
Illustrations: Illustrations
Publication: US
Imprint: Wiley-Blackwell
Returns: Returnable
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