Marginally failed study for Europe [Study As­sess­ment]

posted by balakotu – India, 2018-04-24 07:30  – Posting: # 18726
Views: 1,849

Hi,
I have conducted a full replicate BE study for one of the highly variable product for Europe regulatory.
Based on the reference product variability, relaxed 90% Confidence Intervals is 75.18 to 133.01 for Cmax.
Study marginally failed with 90% upper CI data of 133.18
Is there any way to justify Europe regulatory authority(ies) to accept this study data? (DCP submission)

Regards


Edit: Category changed; see also this post #1 and #4. [Helmut]

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,567 posts in 4,150 threads, 1,340 registered users;
online 7 (0 registered, 7 guests [including 6 identified bots]).
Forum time (Europe/Vienna): 00:22 CEST

Mediocrity knows nothing higher than itself,
but talent instantly recognizes genius.    Arthur Conan Doyle

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5