This book is a compilation of topics addressed by the ASA Biopharmaceutical Section work groups, including the etiology and evolution of the work groups, the work group guidelines and structure, and the statistical issues associated with clinical trials in clinical drug development programs.
1. ASA Biopharmaceutical Section Work Groups 2. Summarization, Analysis, and Monitoring of Adverse Experiences 3. Two Treatment Crossover Designs 4. Active Control Equivalence Studies 5. Optimization in Clinical Trials and Combination Drug Development 6. Dosing in the Elderly 7. Intention to Treat in Clinical Trials 8. Dual Control Groups in Rodent Carcinogenicity Studies