T/R potency <5% [Regulatives / Guidelines]
❝ 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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- T/R potency <5% Achievwin 2022-09-07 18:22 [Regulatives / Guidelines]
- T/R potency <5%Helmut 2022-09-07 18:55