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

posted by jag009  – NJ, 2022-09-08 21:54 (683 d 18:18 ago) – Posting: # 23281
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❝ 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


Correct the "should be within 5%" does exist in the FDA guidance (not the BE guidance for individual products). I was asked to provide the info last yr in a meeting...

John

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