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:
- 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:
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: