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

posted by Achievwin – US, 2022-09-07 20:22 (146 d 12:42 ago) – Posting: # 23275
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Colleagues:

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)

Thanks in advance for your guidance,

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