ceylan
☆    

Turkey,
2021-11-19 15:46
(222 d 01:37 ago)

Posting: # 22676
Views: 955
 

 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 16:22
(222 d 01:01 ago)

@ ceylan
Posting: # 22677
Views: 777
 

 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,
2021-11-20 23:14
(220 d 18:10 ago)

@ ElMaestro
Posting: # 22678
Views: 764
 

 Primary pharmacodynamic bioequivalence

Hi ElMaestro,

Thank you for your help.
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