Course Description

410.651 - Clinical Development of Drugs and Biologics

This course introduces students to the planning and work required to develop potential new drugs and biologics efficiently. Students gain a thorough appreciation of FDA and ICH regulations and guidelines. Because the course emphasizes the importance of planning before the execution of any of the necessary steps, lectures use a "backwards" approach, discussing the final analysis and report before developing protocols. Topics also include an overview of preclinical investigations; NDA/BLA format and content; clinical development plans; product and assay development; the IND; and trial design, implementation, and management. Prerequisites: 410.303 Bioscience for Regulatory Affairs, OR 410.601 Biochemistry and 410.603 Advanced Cell Biology or admission to the MS in Regulatory Science OR Masters of Biotechnology Enterprise and Entrepreneurship programs.