Widening for clopidogrel BE study [Outliers]

posted by mittyri – Russia, 2021-06-16 16:04 (125 d 07:23 ago) – Posting: # 22419
Views: 1,120

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,

Complete thread:

 Admin contact
21,743 posts in 4,546 threads, 1,543 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Tuesday 23:28 CEST (Europe/Vienna)

Sometimes the key to an answer is found
in the way you formulate the question.    David Brin

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