Primary pharmacodynamic bioequivalence [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2021-11-19 17:22 (881 d 16:16 ago) – Posting: # 22677
Views: 1,450

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

Complete thread:

UA Flag
Activity
 Admin contact
22,987 posts in 4,824 threads, 1,663 registered users;
88 visitors (0 registered, 88 guests [including 7 identified bots]).
Forum time: 10:39 CEST (Europe/Vienna)

The only way to comprehend what mathematicians mean by Infinity
is to contemplate the extent of human stupidity.    Voltaire

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5