Statistics in the Pharmaceutical Industry

 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