Bioequivalence for Parenteral Products [Regulatives / Guidelines]

posted by arailkar – 2020-05-29 17:21 (558 d 01:03 ago) – Posting: # 21491
Views: 1,153

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

Complete thread:

Activity
 Admin contact
21,788 posts in 4,557 threads, 1,548 registered users;
online 22 (0 registered, 22 guests [including 5 identified bots]).
Forum time: Wednesday 17:24 CET (Europe/Vienna)

There is no adequate defense, except stupidity,
against the impact of a new idea.    Percy Williams Bridgman

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