BABE for Cefixime Tablets - Canada [Design Issues]

posted by Inder – India, 2018-05-12 09:31  – Posting: # 18761
Views: 1,102

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]

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