Primary pharmacodynamic bioequivalence [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2021-11-19 17:22 (823 d 10:19 ago) – Posting: # 22677
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Hi ceylan,

❝ For PK bioequivalence, 90% confidence interval is ok both for US and EMA.


❝ For PD bioequivalence, I want to ask about the confidence interval for US and EMA?

❝ Is it 90% CI for US and 95% CI for EMA?


❝ And in what circumstances, 90 % CI and / or 95 % CI are being used?


I think the question is a little too general.
Sometimes regulators want a 95% CI other times they want a 90% CI.
Here's a case of a 95% CI being used.
Here's a case of 90% CI being used.

Whatever you do, if you need PD I recommend to go for a scientific advice. Ask about 90% vs 95% if there is nothing written in a guideline. Don't make assumptions and don't take chances.

Pass or fail!
ElMaestro

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