In vitro bioequivalence testing for topical ophthalmic suspension products (17of39) Complex Generics

Darby Kozak from CDER’s Office of Generic Drugs discusses in vitro BE for generic topical ophthalmic
products: when, how and why. Kozak shares the regulatory background and when in vitro testing may be considered / recommended for demonstrating bioequivalence, current thinking on the information to support an in vitro approach, and GDUFA research and development of product-specific guidances for ophthalmic products.
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