T = EV ∧ R = IV ¬ BE (→ absolute BA) [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2020-05-29 17:51 (507 d 03:53 ago) – Posting: # 21492
Views: 728

Hi Ani,

» Dear Helmut,

     ▲▲▲▲▲▲ Not interested in opinions of others?


» I am interested in finding out if bioequivalence study is needed in the US when an IV formulation is changed to a subcutaneous formulation.

That’s not BE but absolute bioavailability.

» I would also appreciate if you can please give me references to US FDA Guidance document that addresses this topic.

Contrary to IV, in SC you have an absorption site. Hence, calling that a “formulation change” is an euphemism. The NDA/IND guidance is a starter.

Dif-tor heh smusma 🖖
Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. 🚮
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