Curriculum
Course Description:
- Excipients in generic drug products are evaluated from clinical and nonclinical perspectives to ensure that they do not alter the safety profile of the formulation as compared to the Reference Listed Drug.
- FDA Pharmacology/Toxicology Review of the proposed level of an excipient includes an evaluation of toxicology data to support the dose, route of administration, duration of exposure and patient population.
Featuring Sruthi King, Ph.D., U.S. FDA
Access Duration:Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.