BABE for Cefixime Tablets - Canada [Design Issues]

posted by Inder – India, 2018-05-12 09:31 (1305 d 09:51 ago) – Posting: # 18761
Views: 3,006

Hello all,

Can anyone please confirm, for (generic) Cefixime tablets, do we need to submit both, Fasting and Fed BE studies in Canada?

As far as i know, we submit Fasting studies for most of the products (uncomplicated IR products) in Canada.

However, somewhere on google, i found an article stating that Cefixime has non-linear kinetics. Therefore, i am not sure if we need to conduct both fasting and fed or only fasting will be fine.

A quick response is really desired.


Edit: Relax; see also this post #9. Please don’t shout[Helmut]

Complete thread:

 Admin contact
21,788 posts in 4,557 threads, 1,548 registered users;
online 7 (0 registered, 7 guests [including 6 identified bots]).
Forum time: Tuesday 18:23 CET (Europe/Vienna)

A big computer, a complex algorithm and a long time
does not equal science.    Robert Gentleman

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