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RegisterBioequivalence for Parenteral Products [Regulatives / Guidelines]
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
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
Complete thread:
- Bioequivalence for Parenteral Productsarailkar 2020-05-29 17:21 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- T = EV ∧ R = IV ¬ BE (→ absolute BA) Helmut 2020-05-29 17:51
Ing. Helmut Schütz