Bioequivalence for Parenteral Products [Regulatives / Guidelines]

posted by arailkar – 2020-05-29 17:21 (279 d 13:05 ago) – Posting: # 21491
Views: 929

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
21,366 posts in 4,462 threads, 1,493 registered users;
online 4 (0 registered, 4 guests [including 2 identified bots]).
Forum time: Friday 05:27 CET (Europe/Vienna)

The statistician has no magic touch by which
he may come in at the stage of tabulation
and make something of nothing.    W. Edwards Deming

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