Statistics In the Pharmaceutical Industry  book cover
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3rd Edition

Statistics In the Pharmaceutical Industry




ISBN 9780824754693
Published September 28, 2005 by CRC Press
504 Pages

 
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Book Description

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.

Table of Contents

Introduction to the Evolution of Pharmaceutical Products; C. Ralph Buncher and Jia-Yeong Tsay
Statistical Review and Evaluation of Animal Carcinogenicity Studies; Karl K. Lin and Mirza W. Ali
The FDA and the IND/NDA Statistical Review Process; Satya D. Dubey, George Y. H. Chi, and Roswitha E. Kelly
Clinical Trial Designs; C. Ralph Buncher and Jia-Yeong Tsay
Selecting Patients for a Clinical Trial; C. Ralph Buncher and Jia-Yeong Tsay
Statistical Aspects of Cancer Clinical Trials; T. Timothy Chen
Recent Statistical Issues and Developments in Cancer Clinical Trials; Weichung Joe Shih
Design and Analysis of Testosterone Replacement Therapy Trials; Ted M. Smith
Clinical Trials of Analgesic Drugs; Cynthia G. McCormick
Statistical Issues in HIV/AIDS Research; Ronald J. Bosch and C. Ralph Buncher
The Wonders of Placebo; C. Ralph Buncher
Active-Controlled Noninferiority/Equivalence Trials: Methods and Practice; Irving K. Hwang
Interim Analysis and Bias in Clinical Trials: The Adaptive Design Perspective; Qing Liu and Gordon Pledger
Interim Analysis and Adaptive Design in Clinical Trials; Irving K. Hwang and K. K. Gordon Lan
A Regulatory Perspective on Data Monitoring and Interim Analysis; Robert T. O’Neill
Complex Adaptive Systems, Human Health and Drug Response: Statistical Challenges in Pharmacogenomics; Kim E. Zerba and C. Frank Shen
Phase IV Postmarketing Studies; C. Ralph Buncher and Jia-Yeong Tsay
The Role of Contract Research Organizations in Clinical Research in the Pharmaceutical Industry; Roger E. Flora and John Constant
Global Harmonization of Drug Development: A Clinical Statistics Perspective; Peter H. van Ewijk, Bernhard Huitfeldt, and Jia-Yeong Tsay
Bridging Strategies in Global Drug Development; Mamoru Narukawa and Masahiro Takeuchi
Design and Analysis Strategies for Clinical Pharmacokinetic Trials; Lianng Yuh and Yusong Chen
Stability Studies of Pharmaceuticals; Yi Tsong, Chi-wan Chen, Wen Jen Chen, Roswitha Kelly, Daphne T. Lin, and Karl K. Lin
When and How to Do Multiple Comparisons; Charles W. Dunnett and Charles H. Goldsmith
Reference Intervals (Ranges): Distribution-Free Methods vs. Normal Theory; Paul S. Horn and Amadeo J. Pesce

Index

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Reviews

"…a broad overview of many of the statistical issues that are faced when doing research in the pharmaceutical industry and therefore it is recommended to individuals who work or consult in this area of statistics. …a useful reference and is recommended for researchers/statisticians who work on problems in the pharmaceutical industry with some regularity."
Biometrics, March 2009

“The first edition of this book appeared in 1981 and the second in 1994 … have come chapters  on testosterone replacement studies, global harmonization, stability studies, bridging studies, reference intervals and there are now three chapters on sequential and adaptive studies where previously there was only one. … The book contains some fine and penetrating chapters. … and useful, summaries. …”
—Stephen Senn, Department of Statistics, University of Glasgow, UK, Statistics in Medicine, Vol. 23-25, 2004-2006

“… Updated and expanded to reflect the most recent trends and developments in the field, this book presents chapters written by experts from both regulatory agencies and pharmaceutical companies that 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, the increasing trend toward non-inferiority/equivalence testing, adaptive designs in clinical trials, global harmonization of regulatory standards, bridging strategies in global drug development, and multiple comparison studies. The book also examines the latest considerations in anti-cancer studies. … includes new chapters on topics such as testosterone replacement therapy trials and active-controlled equivalence trials. It addresses the most current and emerging statistical issues involved in HIV / AIDS research and anti-cancer trials, … The third edition demystifies the approval process by combining regulatory and industrial points of view, making it a mustread for anyone performing statistical analysis at any point in the drug approval process. It is beneficial to biostatisticians and pharmaceutical scientists and researchers who are engaged in the beneficial areas of pharmaceutical research and development”
—T. Postelnicu (Bucuresti), Zentralblatt Math, Vol. 1092, 2006

 “… This is the third edition of the book. This new edition comes with some new chapters and updated material in every chapter to give the reader some insights on the most recent trends and developments in statistical research carried out in the pharmaceutical industry. … the book will help the reader to understand thoroughly all the aspects of statistical research in the pharmaceutical industry. The intended readership of this book is graduated students in statistics or biostatistics, statisticians, and researchers in the health related area who wish to comprehend all the aspects, from a statistical perspective, of what is done in pharmaceutical research and development. It is also a very useful reference book for any researcher who wants to have a good understanding of the issues in pharmaceutical research and development. … We recommend this book for anyone who wishes to learn comprehensively the most current and emerging statistical issues in pharmaceutical research and development.”
—Tulay Koru-Sengul, McMaster University, Technometrics, Vol. 49, No. 2, May 2007

“… 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