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390.631.01
Principles of Drug Development

Location:
East Baltimore
Term:
1st term
Department:
Clinical Investigation
Credits:
2 credits
Academic Year:
2022 - 2023
Instruction Method:
In-person
Class Times:
  • Wednesday,  1:30 - 2:50pm
Auditors Allowed:
No
Grading Restriction:
Letter Grade or Pass/Fail
Course Instructor:
Contact:
Hemalkumar Mehta
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:

This course is evaluated as follows:

  • 100% Exam(s)

Instructor Consent:

Consent required for some students

Consent Note:

PHS Seniors: Instructor permission required

For consent, contact:

hbmehta@jhu.edu