Bioequivalence and Bioavailability Forum

Dear Mr Max,

❝ So if water is consumed while taking high fat breakfast, will it not be violation of the first statement, as this happens during one hour before drug administration?

❝ If not, do we need to standardise the volume of water given for high fat breakfast?

Usually, eight ounces of milk will be provided along with high fat, high calorie breakfast.
If we capture the intake of water in the protocol along with the high fat, high calorie breakfast intake, then it will not be deviation/violation. But, you need to standardize the volume of water to be given along with the fed breakfast to avoid any regulatory query.