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RegisterPrimary pharmacodynamic bioequivalence [Regulatives / Guidelines]
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
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
Complete thread:
- Primary pharmacodynamic bioequivalenceceylan 2021-11-19 15:46
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Primary pharmacodynamic bioequivalence ElMaestro 2021-11-19 16:22
- Primary pharmacodynamic bioequivalence ceylan 2021-11-20 23:14
- Primary pharmacodynamic bioequivalence ElMaestro 2021-11-19 16:22
Ing. Helmut Schütz