Guidance on "AA" rated products [Regulatives / Guidelines]

posted by hnasri – 2014-04-30 22:36 (4438 d 16:27 ago) – Posting: # 12904
Views: 1,660

Does FDA require "AA" rated products bioequivalence data in humans an F2 study (dissolution) is enough?

Edit: Please follow the Forum’s Policy. [Helmut]

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