Primary pharmacodynamic bioequivalence [Regulatives / Guidelines]

posted by ceylan – Turkey, 2021-11-19 16:46 (441 d 01:12 ago) – Posting: # 22676
Views: 1,170

Hi,

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?

Thank you,

Best Regards,

Ceylan

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