Primary pharmacodynamic bioequivalence [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2021-11-19 16:22 (184 d 05:52 ago) – Posting: # 22677
Views: 741

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!

Complete thread:

UA Flag
 Admin contact
22,091 posts in 4,630 threads, 1,566 registered users;
online 15 (0 registered, 15 guests [including 11 identified bots]).
Forum time: Sunday 23:15 CEST (Europe/Vienna)

Competence, like truth, beauty and contact lenses,
is in the eye of the beholder.    Laurence J. Peter

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