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

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

posted by Helmut – Vienna, Austria, 2022-09-07 20:55 (982 d 01:36 ago) – Posting: # 23276
Views: 4,496

Hi Achievwin,

❝ 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.
For Health Canada is was mandatory (‼) to present two evaluations: One ‘as is’ and the other corrected for potency (irrespective whether T and R differed more than 5% or not). Was removed in 2018.
The EMA recommends that you find batches of T and R which differ ≤5%. Only if this is not possible (nope, »we weren’t successful in the pharmacy next door« is not an acceptable justification), in ‘exceptional cases […] content correction could be accepted. If content correction is to be used, this should be pre-specified in the protocol and justified by inclusion of the results from the assay of the test and reference products in the protocol.’

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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