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Zusatztext 109926599 Informationen zum Autor C. Ralph Buncher, Jia-Yeong Tsay Klappentext Updated and expanded to reflect the most recent trends and challenges in pharmaceutical statistics! this third edition presents chapters written by experts from both regulatory agencies and pharmaceutical companies. This approach provides insight into the approval process from those reviewing the statistical analyses as well as those who have had success in getting a new product approved. New and updated chapters reflect the increasingly global nature of the industry! the increasing trend toward non-inferiority 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. Zusammenfassung 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. Inhaltsverzeichnis 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....
