Fluid restriction [Regulatives / Guidelines]

posted by Vyas – India, 2016-10-25 16:30 (3026 d 17:37 ago) – Posting: # 16753
Views: 2,688

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 :confused:

Best regards,
Vyas

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