390.631.01 Principles of Drug Development
- Clinical Investigation
- 1st term
- 2 credits
- Academic Year:
- 2015 - 2016
- East Baltimore
- Class Times:
- Wednesday, 1:30 - 2:50pm
Presents principles underlying preclinical and clinical development of new therapeutic drugs and devices. Describes and evaluates specific examples, and discusses legal and ethical regulations that apply to drug development. Uses a case-based class format.
- 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
- Methods of Assessment:
Student evaluation based on an in-class project presentation and a take-home exam.
- Enrollment Restriction:
Restricted to GTPCI students, CDSE (Pharmacoepidemiology) certificate students, and faculty and staff with active involvement in clinical research
- Instructor Consent:
Consent required for some students
- Consent Note:
Students who are not GTPCI or CDSE (Pharmacoepidemiology) certificate students need permission.
- For consent, contact: