Bioequivalence and Bioavailability Forum • 505 b(2) application & requirement of bioequivalence

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

posted by Mithu – India, 2023-05-04 06:59 (737 d 19:28 ago) – Posting: # 23541
Views: 3,345

Hello All,

My question is, "is it mandatory to have 505b(2) application bio-equivalent to current reference listed drug?"

regards,

Mithu

Complete thread:

505 b(2) application & requirement of bioequivalenceMithu 2023-05-04 04:59 [Regulatives / Guidelines]
- 505 b(2) application & requirement of bioequivalence dshah 2023-05-05 13:38
  - 505 b(2) application & requirement of bioequivalence Mithu 2023-05-11 07:58
- 505 b(2) application & requirement of bioequivalence Achievwin 2023-05-05 16:08
  - 505 b(2) application & requirement of bioequivalence Mithu 2023-05-11 07:58

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