Pillar #1: Drug Development - From Bench to Bedside
Johns Hopkins University
Have you ever taken over the counter or prescription drug? Are you curious about how these drugs are developed, approved and brought to the market? We begin by providing an overview of drug development and approval process and the role regulatory agencies, such as the US Food and Drug Administration, play in the approval process. We discuss phases of clinical trials â phases 1, 2, 3 and 4 â to evaluate efficacy and safety of drug products, along with case studies. We define pharmacoepidemiology
About this Course
Have you ever taken over the counter or prescription drug? Are you curious about how these drugs are developed, approved and brought to the market? We begin by providing an overview of drug development and approval process and the role regulatory agencies, such as the US Food and Drug Administration, play in the approval process. We discuss phases of clinical trials â phases 1, 2, 3 and 4 â to evaluate efficacy and safety of drug products, along with case studies. We define pharmacoepidemiology
What You'll Learn
- Describe the drug development approval process and regulatory agenciesâ role in approval process
- Examine the role of pharmacoepidemiology throughout the drug development process and informing regulatory, clinical and policy decisions
- Identify essential tools and resources to conduct pharmacoepidemiologic studies
Instructors
Hemalkumar Mehta