Bioequivalence and Bioavailability Forum 01:42 CEST

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

BABE for Cefixime Tablets - Canada [Design Issues]

posted by Inder - India, 2018-05-12 09:31  - Posting: # 18761
Views: 686

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.


Thanks,
Inder


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

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,697 posts in 3,982 threads, 1,232 registered users;
online 14 (0 registered, 14 guests [including 12 identified bots]).

I have had my results for a long time:
but I do not yet know how I am to arrive
at them.    Carl Friedrich Gauß

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