Widening for clopidogrel BE study [Outliers]

posted by mittyri – Russia, 2021-06-16 16:04 (341 d 03:23 ago) – Posting: # 22419
Views: 1,551

Dear Loky do

» is widening of Cmax accepted in clopidogrel BE studies with fully replicate design or not?

You linked the EMA Q&A where it is stated unequivocally:
Under these circumstances, the widening of 90% confidence intervals for Cmax is not recommended.

Kind regards,
Mittyri

Complete thread:

UA Flag
Activity
 Admin contact
22,092 posts in 4,630 threads, 1,567 registered users;
online 12 (1 registered, 11 guests [including 8 identified bots]).
Forum time: Monday 19:28 CEST (Europe/Vienna)

There is no adequate defense, except stupidity,
against the impact of a new idea.    Percy Williams Bridgman

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