Bioequivalence and Bioavailability Forum

Dear All

A very warm Good Morning

We are planning to do a study for US submission and we want to put a condition of 24hr pre-dose housing for the same.

Our regulatory team wantsto put a justification for the same in the protocol. And I am totally confused how to write it?

Would this below kind of write up will suffice the need
"Subjects will be housed 24 hr pre-dose for conditioning and required to fast overnight for at least 10 hours until their scheduled dosing time. Fasting will be continued four hours post-dose (Blah.... Blah). "

Or there is any alternate way of writing the same?

Thanks in advance.

Regards
Srinetram