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

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

posted by jag009 – NJ, 2022-09-08 21:54 (1032 d 11:55 ago) – Posting: # 23281
Views: 4,632

❝ 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:

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