Bioequivalence and Bioavailability Forum • Primary pharmacodynamic bioequivalence

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

Complete thread:

Primary pharmacodynamic bioequivalenceceylan 2021-11-19 15:46 [Regulatives / Guidelines]
- Primary pharmacodynamic bioequivalence ElMaestro 2021-11-19 16:22
  - Primary pharmacodynamic bioequivalence ceylan 2021-11-20 23:14