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

posted by Achievwin – US, 2022-09-07 22:50 (531 d 05:00 ago) – Posting: # 23277
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❝ ❝ 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.


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

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