505 b(2) application & requirement of bio­equi­va­lence [Regulatives / Guidelines]

posted by Achievwin – US, 2023-05-05 18:08 (350 d 18:26 ago) – Posting: # 23546
Views: 1,353

Hello Mithu:

505 (b)(2) is all about the submission and marketing strategy. Most of the 505(b)(2) applications take BE route as drug Chemistry, safety and efficacy along with biopharmaceutics is already known and BE is used as a knowledge (claim) gap bridging approach. There are other means you can get 505(b)(2. Please review different guidance (FDA, EMA etc.) or white papers on 505(b)(2).

Hope this helps

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