Clinical Drug Development Data Analysis: Concepts
|PMC 6212||4 Quarter Hours|
|Course Level||CPS - Graduate|
|Description||Examines the process of planning, collecting, analyzing, and reporting data from drug development studies. Focuses on the goals of each phase (1â€“4) of the clinical drug development process and how to achieve these objectives within the confines of the FDA regulations and ICH guidelines. Covers requirements in other countries, including the UK Data Protection Act, issues related to the differences between the development of drugs for oncologic or AIDS indications compared to traditional drugs, cultural influences, current standards of therapy, the need for validated tools, and failure analyses. Prereq. (a) PJM 6000 or (b) BTC 6210, RGA 6100, and either RGA 6201 or RGA 6202.|
PrerequisitesStudents should refer to the Registrar’s Course Catalog for course prerequisite information.