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390.631.01
Principles of Drug Development

Location
East Baltimore
Term
1st Term
Department
Clinical Investigation
Credit(s)
2
Academic Year
2013 - 2014
Instruction Method
TBD
Class Time(s)
Wednesday, 1:30 - 2:50pm
Auditors Allowed
No
Available to Undergraduate
No
Grading Restriction
Letter Grade or Pass/Fail
Course Instructor(s)
Contact Name
Frequency Schedule
Every Year
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 Objectives
Upon successfully completing this course, students will be able to:
  1. Describe how new drugs and devices are taken from the laboratory to the marketplace in the United States
  2. Distinguish Phase I, II, III, and IV studies
  3. 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
Enrollment Restriction
Restricted to GTPCI students, CDSE (Pharmacoepidemiology) certificate students, and faculty and staff with active involvement in clinical research