390.631.01 PRINCIPLES OF DRUG DEVELOPMENT
Department:
Clinical Investigation
Term: 1st term
Credits: (2 credits)
Academic Year: 2012 - 2013
Course Instructor:
- Charles Flexner
Description:
Presents principles underlying preclinical and clinical development of new therapeutic drugs and procedures. Describes and evaluates specific examples, and discusses legal and ethical regulations that apply to drug development.
Student Evaluation: Student evaluation based on an exam.
Learning Objective:
• Describe how new drugs and devices are taken from the laboratory to the marketplace in the United States. • Distinguish Phase I, II, III, and IV studies. • Evaluate the balance between medical benefit, medical risk, economic reward, and economic risk in the decision making process as it relates to drugs and devices in development.
Location: Baltimore
Class Times:
- Wednesday 1:30 - 2:50
Enrollment Minimum: 10
Enrollment Restriction: Restricted to GTPCI students, and faculty and staff with active involvement in clinical research
Instructor Consent:
For consent, contact: gtpci@jhsph.edu
Grading Restriction: Letter Grade or Pass/Fail
Jointly Offered With:
- School of Medicine