Statistics in the Pharmaceutical Industry.

Abstract

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