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RegisterBABE for Cefixime Tablets - Canada [Design Issues]
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]
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:
- BABE for Cefixime Tablets - CanadaInder 2018-05-12 09:31 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BABE for Cefixime Tablets - Canada lakshmiprasad 2018-05-14 07:13
- BABE for Cefixime Tablets - Canada Inder 2018-05-17 08:13
- Nonlinear PK (less than proportional increase in AUC): lowest strength Helmut 2018-05-17 12:11
- BABE for Cefixime Tablets - Canada lakshmiprasad 2018-05-14 07:13
Ing. Helmut Schütz