Bioequivalence for Parenteral Products [Regulatives / Guidelines]

posted by arailkar – 2020-05-29 17:21  – Posting: # 21491
Views: 529

Dear Helmut,

I am interested in finding out if bioequivalence study is needed in the US when an IV formulation is changed to a subcutaneous formulation. I would also appreciate if you can please give me references to US FDA Guidance document that addresses this topic. Thank you very much.

Regards,
Ani

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