Statistics In the Pharmaceutical Industry (Chapman & Hall/CRC Biostatistics Series Book 14)

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. Content: Introduction to the Evolution of Pharmaceutical Products < i> C. Ralph Buncher and Jia-Yeong Tsay< /i> < br> Statistical Review and Evaluation of Animal Carcinogenicity Studies < i> Karl K. Lin and Mirza W. Ali< /i> < br> The FDA and the IND/NDA Statistical Review Process < i> Satya D. Dubey, George Y. H. Chi, and Roswitha E. Kelly< /i> < br> Clinical Trial Designs < i> C. Ralph Buncher and Jia-Yeong Tsay< /i> < br> Selecting Patients for a Clinical Trial < i> C. Ralph Buncher and Jia-Yeong Tsay< /i> < br> Statistical Aspects of Cancer Clinical Trials < i> T. Timothy Chen< /i> < br> Recent Statistical Issues and Developments in Cancer Clinical Trials < i> Weichung Joe Shih< /i> < br> Design and Analysis of Testosterone Replacement Therapy Trials < i> Ted M. Smith< /i> < br> Clinical Trials of Analgesic Drugs < i> Cynthia G. McCormick< /i> < br> Statistical Issues in HIV/AIDS Research < i> Ronald J. Bosch and C. Ralph Buncher< /i> < br> The Wonders of Placebo < i> C. Ralph Buncher< /i> < br> Active-Controlled Noninferiority/Equivalence Trials: Methods and Practice < i> Irving K. Hwang< /i> < br> Interim Analysis and Bias in Clinical Trials: The Adaptive Design Perspective < i> Qing Liu and Gordon Pledger< /i> < br> Interim Analysis and Adaptive Design in Clinical Trials < i> Irving K. Hwang and K. K. Gordon Lan< /i> < br> A Regulatory Perspective on Data Monitoring and Interim Analysis < i> Robert T. O'Neill< /i> < br> Complex Adaptive Systems, Human Health and Drug Response: Statistical Challenges in Pharmacogenomics < i> Kim E. Zerba and C. Frank Shen< /i> < br> Phase IV Postmarketing Studies < i> C. Ralph Buncher and Jia-Yeong Tsay< /i> < br> The Role of Contract Research Organizations in Clinical Research in the Pharmaceutical Industry < i> Roger E. Flora and John Constant< /i> < br> Global Harmonization of Drug Development: A Clinical Statistics Perspective < i> Peter H. van Ewijk, Bernhard Huitfeldt, and Jia-Yeong Tsay< /i> < br> Bridging Strategies in Global Drug Development < i> Mamoru Narukawa and Masahiro Takeuchi< /i> < br> Design and Analysis Strategies for Clinical Pharmacokinetic Trials < i> Lianng Yuh and Yusong Chen< /i> < br> Stability Studies of Pharmaceuticals < i> Yi Tsong, Chi-wan Chen, Wen Jen Chen, Roswitha Kelly, Daphne T. Lin, and Karl K. Lin< /i> < br> When and How to Do Multiple Comparisons < i> Charles W. Dunnett and Charles H. Goldsmith< /i> < br> Reference Intervals (Ranges): Distribution-Free Methods vs. Normal Theory < i> Paul S. Horn and Amadeo J. Pesce< /i> < h3> Index< /h3> Cover 1 Half Title 2 Title Page 4 Copyright Page 5 Dedication 6 Series Introduction 8 Preface to the Third Edition 10 Preface to the Second Edition 12 Preface to the First Edition 14 Contributors 18 Table of Contents 22 Chapter 1 Introduction to the Evolution of Pharmaceutical Products 25 Chapter 2 Statistical Review and Evaluation of Animal Carcinogenicity Studies of Pharmaceuticals 41 Chapter 3 The FDA and the IND/NDA Statistical Review Process 79 Chapter 4 Clinical Trial Designs 103 Chapter 5 Selecting Patients for a Clinical Trial 115 Chapter 6 Statistical Aspects of Cancer Clinical Trials 139 Chapter 7 Recent Statistical Issues and Developments in Cancer Clinical Trials 159 Chapter 8 Design and Analysis of Testosterone Replacement Therapy Trials 175 Chapter 9 Clinical Trials of Analgesic Drugs 185 Chapter 10 Statistical Issues in HIV/AIDS Research 197 Chapter 11 The Wonders of Placebo 207 Chapter 12 Active-Controlled Noninferiority/Equivalence Trials: Methods and Practice 217 Chapter 13 Interim Analysis and Bias in Clinical Trials: The Adaptive Design Perspective 255 Chapter 14 Interim Analysis and Adaptive Design in Clinical Trials 269 Chapter 15 A Regulatory Perspective on Data Monitoring and Interim Analysis 309 Chapter 16 Complex Adaptive Systems, Human Health, and Drug Response: Statistical Challenges in Pharmacogenomics 319 Chapter 17 Phase IV Postmarketing Studies 327 Chapter 18 The Role of Contract Research Organizations in Clinical Research in the Pharmaceutical Industry 339 Chapter 19 Global Harmonization of Drug Development — A Clinical Statistics Perspective 349 Chapter 20 Bridging Strategies in Global Drug Development 369 Chapter 21 Design and Analysis Strategies for Clinical Pharmacokinetic Trials 381 Chapter 22 Stability Studies of Pharmaceuticals 415 Chapter 23 When and How to Do Multiple Comparisons 445 Chapter 24 Reference Intervals (Ranges): Distribution-Free Methods vs. Normal Theory 477 Index 493 "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 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 design 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." "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."--BOOK JACKET Updated and expanded to reflect the recent trends and challenges in pharmaceutical statistics, this third edition presents chapters written by experts from both regulatory agencies and pharmaceutical companies.