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

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

posted by dshah – India/United Kingdom, 2022-09-09 12:48 (591 d 22:59 ago) – Posting: # 23282
Views: 2,406

Hi Achievwin!
Unlike Health Canada, there is no provision for potency correction in FDA.
So if the difference is more, there is higher probability to find difference in PK parameters for treatments, which ultimately affects BE outcome.
It's best to have less difference in Assay of Test and Reference for any BE study.
Regards,
Divyen

Complete thread:

T/R potency <5% Achievwin 2022-09-07 18:22
- 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