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Course Catalog

390.631.01 Principles of Drug Development

Department:
Clinical Investigation
Term:
1st term
Credits:
2 credits
Academic Year:
2017 - 2018
Location:
East Baltimore
Class Times:
  • Wednesday,  1:30 - 2:50pm
Auditors Allowed:
Yes, with instructor consent
Grading Restriction:
Letter Grade or Pass/Fail
Contact:
Cristina DeNardo
Course Instructor:
Resources:
Description:

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:

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
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:

gtpci@jhsph.edu