Bioequivalence and Bioavailability Forum • T/R potency <5%

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

posted by Achievwin – US, 2022-09-07 22:50 (153 d 00:47 ago) – Posting: # 23277
Views: 1,199

❝ ❝ 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:

T/R potency <5% Achievwin 2022-09-07 18:22 [Regulatives / Guidelines]
- T/R potency <5% Helmut 2022-09-07 18:55
  - T/R potency <5%Achievwin 2022-09-07 20:50
    - T/R potency <5% jag009 2022-09-08 19:54
    - T/R potency <5% dshah 2022-09-09 10:48
      - T/R potency <5% Helmut 2022-09-09 12:13
      - T/R potency <5% Achievwin 2022-09-09 14:56
        
        T/R potency <5% Helmut 2022-09-09 17:08
        T/R potency <5% dshah 2022-09-09 17:42