Water requirement in Fed state studies [Study Performance]
Dear Mr Max,
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.
❝ 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.
—
Dr S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.
Dr S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.
Complete thread:
- Water requirement in Fed state studies ClinResBE 2014-09-26 18:34
- Water requirement in Fed state studiesdrgunasakaran1 2014-10-01 18:29