TY - BOOK ID - 25747407 TI - Statistical issues in drug development PY - 2000 SN - 0471974889 9780471974888 PB - Chichester Wiley DB - UniCat KW - Mathematical statistics KW - QV 771 Standardization and evaluation of drugs KW - Clinical Trials KW - Drug development KW - Statistical methods KW - Drug Industry KW - Clinical Trials as Topic KW - Statistics as Topic KW - Drug Design KW - methods KW - Statistics KW - Drug development - Statistical methods KW - Statistics as Topic - methods UR - https://www.unicat.be/uniCat?func=search&query=sysid:25747407 AB - Statistics in Practice A new series of practical books outlining the use of statistical techniques in a wide range of application areas:* Human and Biological Sciences* Earth and Environmental Sciences* Industry, Commerce and FinanceStatistical Issues in Drug Development Stephen Senn Professor of Pharmaceutical & Health Statistics, University College, London Statistical Issues in Drug Development provides an accessible text for those working directly in drug development, regulatory and marketing departments within the pharmaceutical industry. As a consequence of regulatory authorities demanding increasingly higher standards, statistics has become a critical element in the design and conduct of drug development programmes. The concepts covered in this volume guide the non-statistician through the most pressing statistical issues and controversies in drug development. Key issues covered include:* Design & interpretation of clinical trials* Bayesian & frequentist methods* Sequential & cross-over trials* Drug monitoring & pharmaco-economicsThe book has been prepared in two sections. The first section considers the role of statistics in drug development from four different perspectives: historical, philosophical, technical and professional. The second section covers a series of controversial topics 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 make it invaluable to all those working in drug development and regulation. ER -