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![]( "Buchcover ISBN 9780470723579")
For all his contributions to the development and exposition ofmedical statistics Stephen Senn is awarded the 2009 BradfordHill Medal by the Royal Statistical Society.
? This book is a thought provoking, intriguing, and oftenchallenging read. The author is unafraid to tackle weightyphilosophical and paradigmatic issues, and he generally does sowith great skill and insight. ... this excellent book should serveto inspire both statisticians and life scientists.? (Journal ofthe American Statistical Association, September 2009)
„For statisticians, this should be required reading for anyoneconsidering or starting out on a career in clinical drugdevelopment. I am also quite sure that most experiencedstatisticians would find this a useful book to dip into on occasion... . This book will not disappoint.“ (Journal of the RoyalStatistical Society: Series A (Statistics in Society), April 2009)
„This book is an outstanding effort from a statistician ofheroic proportions. Someone like me is only capable of sitting onthe curb and applauding wildly.“ (Journal of BiopharmaceuticalStatistics, Volume 19, Issue 1, 2009)
Statistical Issues in Drug Development
von Stephen S SennDrug 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.
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.
