BABE for Cefixime Tablets - Canada [Design Issues]

posted by Inder – India, 2018-05-12 09:31 (932 d 14:19 ago) – Posting: # 18761
Views: 2,581

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
21,220 posts in 4,427 threads, 1,481 registered users;
online 13 (0 registered, 13 guests [including 12 identified bots]).
Forum time: Sunday 22:51 CET (Europe/Vienna)

Half the harm that is done in this world
Is due to people who want to feel important.    T. S. Eliot

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