BIOS 7431Statistical Issues in Drug Development: 3-0-3 Major statistical issues in the federal regulation of drug research and clinical development will be studied. Specifically, summarization, analysis and monitoring of adverse experiences, two treatment crossover designs, active control equivalence studies, optimization in clinical trials and combination drug development, dosing in the elderly, intention to treat in clinical trials, and dual control groups in rodent carcinogenicity studies will be studied. Prerequisites: BIOS 6331 and BIOS 6332 or equivalent. | |||