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![]( "Buchcover ISBN 9780470866658")
Statistical Issues in Drug Development
von Stephen S SennStatistics in Practice A new series of practical books outliningthe use of statistical techniques in a wide range of applicationareas:
* Human and Biological Sciences
* Earth and Environmental Sciences
* Industry, Commerce and Finance
Statistical Issues in Drug Development Stephen Senn Professor ofPharmaceutical & Health Statistics, University College, LondonStatistical Issues in Drug Development provides an accessible textfor those working directly in drug development, regulatory andmarketing departments within the pharmaceutical industry. As aconsequence of regulatory authorities demanding increasingly higherstandards, statistics has become a critical element in the designand conduct of drug development programmes. The concepts covered inthis volume guide the non-statistician through the most pressingstatistical issues and controversies in drug development. Keyissues covered include:
* Design & interpretation of clinical trials
* Bayesian & frequentist methods
* Sequential & cross-over trials
* Drug monitoring & pharmaco-economics
The book has been prepared in two sections. The first sectionconsiders the role of statistics in drug development from fourdifferent perspectives: historical, philosophical, technical andprofessional. The second section covers a series of controversialtopics such as fixed versus random effects for meta-analysis, one-sided versus two-sided tests and the ethics of placebo run-ins. The approachable and wide-ranging coverage of this book will makeit invaluable to all those working in drug development andregulation.
* Human and Biological Sciences
* Earth and Environmental Sciences
* Industry, Commerce and Finance
Statistical Issues in Drug Development Stephen Senn Professor ofPharmaceutical & Health Statistics, University College, LondonStatistical Issues in Drug Development provides an accessible textfor those working directly in drug development, regulatory andmarketing departments within the pharmaceutical industry. As aconsequence of regulatory authorities demanding increasingly higherstandards, statistics has become a critical element in the designand conduct of drug development programmes. The concepts covered inthis volume guide the non-statistician through the most pressingstatistical issues and controversies in drug development. Keyissues covered include:
* Design & interpretation of clinical trials
* Bayesian & frequentist methods
* Sequential & cross-over trials
* Drug monitoring & pharmaco-economics
The book has been prepared in two sections. The first sectionconsiders the role of statistics in drug development from fourdifferent perspectives: historical, philosophical, technical andprofessional. The second section covers a series of controversialtopics such as fixed versus random effects for meta-analysis, one-sided versus two-sided tests and the ethics of placebo run-ins. The approachable and wide-ranging coverage of this book will makeit invaluable to all those working in drug development andregulation.
