390.631.01
Drug Development and Real-World Evidence (RWE)
Location
East Baltimore
Term
1st Term
Department
Clinical Investigation
Credit(s)
2
Academic Year
2025 - 2026
Instruction Method
In-person
Wednesday, 1:30 - 2:50pm
Auditors Allowed
No
Available to Undergraduate
Yes
Grading Restriction
Letter Grade or Pass/Fail
Course Instructor(s)
Contact Name
Frequency Schedule
Every Year
Resources
Prerequisite
Enrollment Restriction
This course is not restricted.
Have you ever taken an over-the-counter or prescription drug? Are you curious about how those drugs are developed, approved and brought to the market? If you want to learn about the drug development process, this class is for you! Still unsure? Did you enjoy watching 鈥淗ow It鈥檚 Made鈥 as a kid? If yes, you will enjoy this course.
Provides an overview of the development of a new therapeutic drug, from laboratory research to final approval and beyond. Covers the different phases of the drug development process and the role of regulatory agencies, such as the U.S. Food and Drug Administration. Explores the value and need of real-world evidence on the drug development process. Includes case studies of drug approvals to illustrate key concepts in the drug development process.
Learning Objectives
Upon successfully completing this course, students will be able to:
- Formulate an approach to drug development and consider the challenges inherent within that approach
- Differentiate the various steps involved in the drug development pathway
- Distinguish Phase I, II, III, and IV studies
- Evaluate the role of real-world evidence in the drug development process
Upon successfully completing this course, students will be able to:
Methods of Assessment
This course is evaluated as follows:
- 10% Participation
- 20% Midterm
- 20% Final Exam
- 50% Final Project