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Author:   C. Ralph Buncher ,  Jia-Yeong Tsay ,  Shein-Chung Chow (Duke Univ, USA) ,  Satya D. Dubey (Bethesda, Maryland, USA)
Publisher:   Taylor & Francis Ltd
Imprint:   CRC Press
Edition:   3rd edition
Weight:   2.020kg
ISBN:  

9781032477879

ISBN 10:   1032477873
Pages:   496
Publication Date:   21 January 2023
Audience:   College/higher education ,  Tertiary & Higher Education
Format:   Paperback
Publisher's Status:   Active
Availability:   In Print  
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Table of Contents

Introduction to the Evolution of Pharmaceutical Products. Statistical Review and Evaluation of Animal Carcinogenicity Studies. The FDA and the IND/NDA Statistical Review Process. Clinical Trial Designs. Selecting Patients for a Clinical Trial. Statistical Aspects of Cancer Clinical Trials. Recent Statistical Issues and Developments in Cancer Clinical Trials. Design and Analysis of Testosterone Replacement Therapy Trials. Clinical Trials of Analgesic Drugs. Statistical Issues in HIV/AIDS Research. The Wonders of Placebo. Active-Controlled Noninferiority/Equivalence Trials: Methods and Practice. Interim Analysis and Bias in Clinical Trials: The Adaptive Design Perspective. Interim Analysis and Adaptive Design in Clinical Trials. A Regulatory Perspective on Data Monitoring and Interim Analysis. Complex Adaptive Systems, Human Health and Drug Response: Statistical Challenges in Pharmacogenomics. Phase IV Postmarketing Studies. The Role of Contract Research Organizations in Clinical Research in the Pharmaceutical Industry. Global Harmonization of Drug Development: A Clinical Statistics Perspective. Bridging Strategies in Global Drug Development. Design and Analysis Strategies for Clinical Pharmacokinetic Trials. Stability Studies of Pharmaceuticals. When and How to Do Multiple Comparisons. Reference Intervals (Ranges): Distribution-Free Methods vs. Normal Theory. Index.

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

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C. Ralph Buncher, Jia-Yeong Tsay

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