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

posted by Achievwin – US, 2022-09-07 22:50 (567 d 11:56 ago) – Posting: # 23277
Views: 2,342

❝ ❝ Somewhere in the Bioequivalence guidance I remembered that when designing the studies we try to keep T/R potency +/-5%. Can someone point out where this kind of condition existed, (latest guidance has no mention of this)


❝ – AFAIK, it was never stated by the FDA in any guidance.


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

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,640 registered users;
81 visitors (0 registered, 81 guests [including 5 identified bots]).
Forum time: 09:47 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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