BIOS 7431 - Statistical Issues in Drug Development (3 Credit Hours)

Lecture Hours: 3 Lab Hours: 0
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.

Prerequisite(s): A minimum grade of “B” in all of the following: PUBH 6541, BIOS 7535, BIOS 7544, or permission of instructor.
Restriction(s): NO Undergraduate Level Students