ceylan
☆    

Turkey,
2021-11-19 16:46
(881 d 17:28 ago)

Posting: # 22676
Views: 1,687
 

 Primary 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
ElMaestro
★★★

Denmark,
2021-11-19 17:22
(881 d 16:52 ago)

@ ceylan
Posting: # 22677
Views: 1,453
 

 Primary pharmacodynamic bioequivalence

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
ceylan
☆    

Turkey,
2021-11-21 00:14
(880 d 10:01 ago)

@ ElMaestro
Posting: # 22678
Views: 1,400
 

 Primary pharmacodynamic bioequivalence

Hi ElMaestro,

Thank you for your help.
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