Course Description:
The goals of the workshop included the following:
- Advance the science of excipient selection and regulatory evaluation.
- Emphasize that regulatory science is decision science.
- Recognize that better and faster decisions about excipients are needed.
- Encourage innovation in product development.
- Present and discuss examples of how excipients have activity, functions and side effects that impact drug product performance and equivalence.
- Develop a mutual understanding of the need for expanded access to complex generics.
Ronald Piervincenzi, Ph.D., USP CEO
This workshop was the most-subscribed workshop in USP’s history, which reflected the importance of excipients. Although the workshop focused on excipients, its impact will be broader.
Jaap Venema, Ph.D., USP Chief Science Officer
Excipients are critical to quality and are a key component of medicines, foods and dietary supplements. Excipient variability and supply chain monitoring are key issues. A path for the introduction of novel excipients is needed. Workshop Goals and Anticipated Outcomes
Robert Lionberger, Ph.D., U.S. FDA
Access Duration:Access to this course expires 6 months from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.