Strategies for Generic Topical Product Development (7of35) Complex Generics– Sep. 25-26, 2019

Tannaz Ramezanli from the Division of Therapeutic Performance in the Office of Generic Drugs covers considerations related to the formulation of the test product. She also discusses bioequivalence (BE) approaches, considerations related to physical and structural (Q3) characterizations and the packaging configurations.

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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

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