arailkar
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2020-05-29 17:21
(484 d 11:55 ago)

Posting: # 21491
Views: 1,138
 

 Bioequivalence 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
Helmut
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2020-05-29 17:51
(484 d 11:24 ago)

@ arailkar
Posting: # 21492
Views: 726
 

 T = EV ∧ R = IV ¬ BE (→ absolute BA)

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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