AUCt not covering at least 80% of AUCinf [Regulatives / Guidelines]

posted by ratnakar1811 – India, 2013-03-06 09:50 (4149 d 18:18 ago) – Posting: # 10157
Views: 25,212

Dear d_labes/forum members,

Yes, in more than 20% of observations AUCinf has been extrapolated for more than 20% and i have received a query from EMA to discuss the validity of the study.

I am just thinking what all points should be considered for the justification and further is there any way by which it can be justified?

Best Regards,

Ratnakar

Complete thread:

UA Flag
Activity
 Admin contact
23,101 posts in 4,857 threads, 1,644 registered users;
61 visitors (0 registered, 61 guests [including 4 identified bots]).
Forum time: 05:09 CEST (Europe/Vienna)

One can show the following: given any rule, however “fundamental”
or “necessary” for science, there are always circumstances
when it is advisable not only to ignore the rule,
but to adopt its opposite.    Paul Feyerabend

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