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Best Practices for Utilizing Modeling Approaches to Support Generic Product Development

FDA-CRCG Workshop October 27-28, 2022

October 27 (8:30 AM-5:00 PM)
October 28 (8:30 AM-3:40 PM)

The purpose of this two-day workshop is to discuss and illustrate how generic product developers can utilize modeling approaches in conjunction with in vitro data and other knowledge to support the development of complex generics that may otherwise rely upon challenging in vivo studies to demonstrate bioequivalence.

For more information about the workshop please visit: https://complexgenerics.org/modeling-approaches/