Statistics in the Pharmaceutical Industry

Furnishing balanced, comprehensive information on the wide-ranging applications of statistics in the pharmaceutical field, the Second Edition covers essential topics, such as cancer clinical trials, AIDS clinical trials, and animal tumorigenicity studies the role of epidemiology in postmarketing trials and adverse drug experience Computer-Assisted New Drug Application (CANDA) submissions contract research organizations interim analysis in clinical trials and more!

... I found many chapters interesting ... I particularly enjoyed the chapters on reference intervals, interim analysis, bridging studies, and multiple comparisons ... Buncher's essay on the placebo also makes thought-provoking reading ... [the book is] a work that deserves to find its way into most departmental libraries ...
-Statistics in Medicine, 2007

The third edition of this book represents a well-organized and thorough exploration of many of the key aspects of statistical application in the pharmaceutical industry. The graduate student, academic statistician interested in pharmaceutical applications, and novice statisticians in both the industrial and regulatory environments, can benefit from the presentation in each of the chapters. Experienced statisticians in both the industrial and regulatory environments can benefit from the current references in chapters covering their therapeutic area and in learning about other therapeutic areas for career development. ...This book is recommended as an up-to-date reference for statisticians and scientists engaged in the pharmaceutical research (both industrial and regulatory) or anyone who wishes to learn about the role of the statistician in the pharmaceutical industry.
-Journal of Biopharmaceutical Statistics