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RegisterT = EV ∧ R = IV ¬ BE (→ absolute BA) [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2020-05-29 19:51 (1697 d 13:53 ago) – Posting: # 21492
Views: 1,626
Hi Ani,
That’s not BE but absolute bioavailability.
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.
❝ 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.
—
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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Bioequivalence for Parenteral Products arailkar 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