Statistics In the Pharmaceutical Industry
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. 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.
C. Ralph Buncher, Jia-Yeong Tsay