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390.631.01 PRINCIPLES OF DRUG DEVELOPMENT

Department: Clinical Investigation
Term: 1st term
Credits: 2 credits
Contact: Cristina DeNardo
Academic Year: 2013 - 2014
Course Instructor:
Description:

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.

Learning Objective(s):
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

Methods of Assessment: Student evaluation based on an exam.
Location: East Baltimore
Class Times:
  • Wednesday 1:30 - 2:50
Enrollment Minimum: 10
Enrollment Restriction: Restricted to GTPCI students, CDSE (Pharmacoepidemiology) certificate students, and faculty and staff with active involvement in clinical research
Instructor Consent: No consent required
Auditors Allowed: No
Grading Restriction: Letter Grade or Pass/Fail