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

posted by dshah  – India/United Kingdom, 2023-05-05 15:38 (147 d 14:26 ago) – Posting: # 23545
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Hello Mithu!

As we rely on existing PKPD relationship, toxicity data and other pharmacology data of reference drug, the BE is required.

Regards,
Divyen

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