Statistical Issues in Drug Development (Statistics in Practice) - Tapa dura

The statistical issues in drug development are explained in this book, enabling non-statistians to work more easily alongside their statistical colleagues in planning, analysing and interpreting clinical trials. The author aims to make the book of particularly benefit to the physician who might have little access to statistical expertise. Drug development brings its own commercial pressures whilst regulatory standards determine that much of the work is examined very closely. As a consequence, the non-statistician working in drug development has to possess considerable appreciation of statistical issues, and this book aims to provide that.

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 Finance
Statistical 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-economics
The 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.