Section outline

  • No Attendance Required: How to Assess an Early Stage Drug Candidate and Drug Development Lessons
    Characteristics of a good drug; target and validation: assessment; biology and animal models; chemical characteristics; pharmacokinetics; regulatory path; case studies. Case studies on drug development including: CAST; FIAU; TGN-1412; gene therapy.

    Faculty:  Richard Chin

    Location: 

    • Session Slides:

    • Lecture 2-1 File

    • Required Reading/Viewing:

    • Drugs at the FDA URL

    • Assignment: Homework Assignment due April 15: Pick a drug that has an FDA review posted, and read the clinical review, the approval letter, and the package insert. Based on this, and knowledge of the indication, please write a target product profile. Students should email their assignments to Marlene Grenon and bring a copy to this lecture.

    • CaseStudyAssign 2012 File

    • Assignment Due Date:  Case Study Assignment due April 15th: Email to marlene.grenon@ucsf.edu