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

posted by Mithu – India, 2023-05-04 06:59 (446 d 09:13 ago) – Posting: # 23541
Views: 2,048

Hello All,


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

regards,

Mithu

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