390.631.01 PRINCIPLES OF DRUG DEVELOPMENT
- Charles Flexner
Presents principles underlying preclinical and clinical development of new therapeutic drugs, devices, and diagnostic tests. Describes and evaluates specific examples, and discusses legal and ethical regulations that apply to drug development. Uses a case-based class format.
Upon successfully completing this course, students will be able to:
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
- Wednesday 1:30 - 2:50