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

posted by Helmut Homepage – Vienna, Austria, 2020-05-29 17:51 (115 d 18:27 ago) – Posting: # 21492
Views: 445

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
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Activity
 Admin contact
21,069 posts in 4,392 threads, 1,466 registered users;
online 16 (1 registered, 15 guests [including 6 identified bots]).
Forum time: Tuesday 12:18 CEST (Europe/Vienna)

Everybody is a Bayesian.
It’s just that some know it, and some don’t.    Trivellore Raghunathan

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5