Statistics in the Pharmaceutical Industry

The growth of the pharmaceutical industry over the past decade is astounding, but the impact of this growth on statistics is somewhat confusing. While software has made analysis easier and more efficient, regulatory bodies now demand deeper and more complex analyses, and pharmacogenetic/genomic studies serve up an entirely new set of challenges. For more than two decades, Statistics in the Pharmaceutical Industry has been the definitive guide to sorting through the challenges in the industry, and this Third Edition continues that tradition.

Updated and expanded to reflect the most recent trends and developments in the field, Statistics in the Pharmaceutical Industry, Third Edition presents chapters written by experts from both regulatory agencies and pharmaceutical companies who discuss everything from experimental design to post-marketing studies. This approach sheds light on what regulators consider acceptable methodologies and what methods have proven successful for industrial statisticians. Both new and revised chapters reflect the increasingly global nature of the industry as represented by authors from Japan and Europe, the increasing trend toward non-inferiority/equivalence testing, adaptive design in clinical trials, global harmonization of regulatory standards, and multiple comparison studies. The book also examines the latest considerations in anti-cancer studies.

Statistics in the Pharmaceutical Industry, Third Edition demystifies the approval process by combining regulatory and industrial points of view, making it a must-read for anyone performing statistical analysis at any point in the drug approval process.

... 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