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 410.602 Molecular Biology

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