Experimental Therapeutics

3.0 credits

This course is designed for individuals interested in the process for identifying novel interventions for diseases, and for their eventual introduction into humans. Topic areas covered will include: preclinical assessment of an intervention's ability to modulate disease, the preclinical safety data needed before initiating human experimentation, the appropriate techniques for extrapolating dosages from animals to humans; types of human experimentation (Phase 1-Phase 3 clinical trials), the level of animal and human evidence necessary to progress from one phase of experimentation to the next, and the ethical underpinnings of human experimentation. (Including CTSI Skill-Building Workshop Series Seminar: Good Advice: Case Studies in Clinical Research, Regulation, and the Law).