Log in
RegisterBABE for Cefixime Tablets - Canada [Design Issues]
hi,
good morning,
As per canadian guidelines the fasting and fed study was required for only modified formulations. So, I think we can go with fasting study and I was checked literature i didnt find any non-linear things in kinetics. So, my suggestion is fasting study.
Edit: Full quote removed (as in all of your replies so far: first warning). Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]
good morning,
As per canadian guidelines the fasting and fed study was required for only modified formulations. So, I think we can go with fasting study and I was checked literature i didnt find any non-linear things in kinetics. So, my suggestion is fasting study.
Edit: Full quote removed (as in all of your replies so far: first warning). Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]
Complete thread:
- BABE for Cefixime Tablets - Canada Inder 2018-05-12 09:31 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BABE for Cefixime Tablets - Canadalakshmiprasad 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 - Canadalakshmiprasad 2018-05-14 07:13
Ing. Helmut Schütz