Primary pharmacodynamic bioequivalence [Regulatives / Guidelines]
Hi ceylan,
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.
❝ 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
Pass or fail!
ElMaestro
Complete thread:
- Primary pharmacodynamic bioequivalence ceylan 2021-11-19 15:46 [Regulatives / Guidelines]
- Primary pharmacodynamic bioequivalenceElMaestro 2021-11-19 16:22
- Primary pharmacodynamic bioequivalence ceylan 2021-11-20 23:14
- Primary pharmacodynamic bioequivalenceElMaestro 2021-11-19 16:22