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

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

posted by dshah – India, 2022-09-09 19:42 (760 d 12:18 ago) – Posting: # 23287
Views: 3,173

Hi Achievwin!

Just trying to be simple, lets assume a T/R ratio of 90-111.1%. Based on your spec, assay limit can be +/- 10%.
The assay of test for assumption is 95% and Ref is 105%. With such scenario, it can be assumed that your T/R ratio can be on lower side and vice versa.
But if assay of test is 98% and ref is 102% (difference is LT 5%), the 90% CI limit can have higher probability be tighter than the previous case.
The ageing impact can vary with drug product, and thus it should be considered on case by case basis.
The overages (for e.g. Vitamins) can also be a challenge in such scenario.
Meeting your target for exact assay can be challenging in manufacturing where loss is observed resulting in to lower assay.

Thank you Helmut for the point in Health Canada.

Regards,
Divyen

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