Section outline

  • Discussion Seminar: Introduction
    History and phases of drug development, role of regulatory agencies; ethics of drug development; program design; intellectual property.

    Faculty:  Richard Chin

    Location:     Mission Hall 1106

    • Session Slides:

    • DrugDev Lecture1-1 File

    • Required Reading/Viewing:

    • Guidance documents URL
    • FDA guidance documents URL

    • Resources:

    • Zepeda EPI260 Case Study File
    • Dronaderone Case Study File
    • Epi260 - Case Study knishimura File

    • Assignment: Read a guidance document from FDA or EMA on an indication of your choice and write up your thoughts on the indication, the endpoints, magnitude of clinical benefit that the agency expects, and what you see as strengths and weaknesses of the document.

       

    • Assignment Due Date:  Due April 8: Students should email their assignments to Marlene Grenon at marlene.grenon @ucsf.edu and bring a copy to this lecture.