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Principles of Drug Development

East Baltimore
1st Term
Clinical Investigation
Academic Year
2024 - 2025
Instruction Method
Class Time(s)
Wednesday, 1:30 - 2:50pm
Auditors Allowed
Available to Undergraduate
Grading Restriction
Letter Grade or Pass/Fail
Course Instructor(s)
Contact Name
Frequency Schedule
Every Year
Have you ever taken an over-the-counter or prescription drug? Are you curious how those drugs are approved and brought to the market? If you want to learn about the drug development process and its complexities, this class is for you!
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. Evaluates the role of the FDA, critically, throughout the drug development process.
Learning Objectives
Upon successfully completing this course, students will be able to:
  1. Formulate an approach to drug development and consider the challenges inherent within that approach
  2. Differentiate the various steps involved in the drug development pathway
  3. Distinguish Phase I, II, III, and IV studies
  4. 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:
  • 40% Quizzes
  • 10% Participation
  • 50% Final Project