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.

Course Learning Objectives

• 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.