Drug Discovery and Development

Catalog description

Provides an overview of the procedures and the structure of drug discovery and development from preclinical candidate selection to new drug application (NDA) approval and the post marketing surveillances. Students will gain an understanding of FDA structure and its various centers, role of regulatory authorities, laws, regulations and policies for drug application, as well as reviewing the time line and components of clinical phases. In addition students gain an understanding of the role of Institutional Animal Care and Use Committees (IACUC) in drug discovery, and the role of Institutional Review Boards (IRB) in drug development.