T/R potency <5% [Regulatives / Guidelines]

posted by jag009  – NJ, 2022-09-08 21:54 (796 d 19:31 ago) – Posting: # 23281
Views: 3,461

❝ It was there in 2001 guidance as desired requirement-not mandatory... problem is that I can not find that 2001 (first) BE/BA guidance

❝ I can not find that 2001 (first) BE/BA guidance. Also in 2021 guidance lines 807-808


Correct the "should be within 5%" does exist in the FDA guidance (not the BE guidance for individual products). I was asked to provide the info last yr in a meeting...

John

Complete thread:

UA Flag
Activity
 Admin contact
23,297 posts in 4,892 threads, 1,691 registered users;
19 visitors (0 registered, 19 guests [including 8 identified bots]).
Forum time: 16:26 CET (Europe/Vienna)

Laws are like sausages – it is better
not to see them being made.    Otto von Bismarck

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