Learn how small molecule drugs are discovered, validated, and optimized.

Learn the process used to discover new biologics.

Learn the regulatory considerations from preclinical studies, to clinical studies, to final market ...

Learn the preclinical criteria needed to support first-in-human clinical testing.

Learn the FDA-required testing and safety assessments needed to for a successful IND.

Learn the basic principles and processes of clinical development.

Learn which studies are undertaken, their purpose, and the common endpoints of a successful Phase I ...

Learn the purpose, trial designs, and the FDA and EMA special designations for Phase II and III cli...

Learn the ongoing post-approval clinical assessments required by regulatory agencies.

This course focuses on the discovery considerations of therapeutic antibodies.