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)
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❝ – 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
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
- T/R potency <5%Achievwin 2022-09-07 20:50
- T/R potency <5% Helmut 2022-09-07 18:55