Kristina Tkachenko
This course provides an overview of the drug development and clinical trials processes. Topics include the discovery of new molecules, how discoveries become drugs or devices, the purpose of clinical and pharmaceutical research and development, the economics of drug development, cost/benefit analyses in clinical development, Phase I-IV clinical trials, and an introduction to the special problems of each phase.
Skills / Knowledge
- Define and understand the differences between Phase I, II, III, and IV trials.
- Define what preclinical work consists of, including toxicology and pharmacology.
- Develop timelines for the process, such as discovery through NDA.
- Demonstrate development plans, NDA submission, required FDA meetings, and what happens and why during the approval process.
- Provide a general overview and history of the regulatory process.
- Provide an overview of human subject protections.
Issued on
April 7, 2025
Expires on
Does not expire