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Statistical Issues in Drug Development, 2nd Edition

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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…

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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. Key features 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. 522 p.

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Authors expertises affiliations

  • Stephen Senn. Department of Statistics. University of Glasgow (UK).
  • Publication date (digital version): 2008-01 – Wiley-Interscience; Copyright © 2007 by John Wiley & Sons Ltd.

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7 December 2019

Stephen Senn has been awarded the Bradford Hill Medal by the Royal Statistical Society.

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