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RegisterFluid restriction [Regulatives / Guidelines]
Hi All,
Almost all regulatory bodies emphasize on pre & post dosing fluid restriction in BE studies. I agree on one of the main assumptions in a cross-over setting which is constant clearances within study periods.
What is FDA's thinking on allowing milk (fluid) to be served to the subjects 30 minutes prior to dosing as a part of high fat breakfast & restricting other fluids one hour before and after drug administration
Best regards,
Vyas
Almost all regulatory bodies emphasize on pre & post dosing fluid restriction in BE studies. I agree on one of the main assumptions in a cross-over setting which is constant clearances within study periods.
What is FDA's thinking on allowing milk (fluid) to be served to the subjects 30 minutes prior to dosing as a part of high fat breakfast & restricting other fluids one hour before and after drug administration
Best regards,
Vyas
Complete thread:
- Fluid restrictionVyas 2016-10-25 14:30
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Fluid restriction Dr_Dan 2016-11-02 15:21
Ing. Helmut Schütz