Bioequivalence and Bioavailability Forum

Dear Raghavendra,

❝ In a BA/BE study, on the day of check-in due to unavoidable reasons if the check-in happens late night say about 12midnight

OK

❝ is it ok with the restrictions and prohibitions mentioned in the protocol as they are going to file protocol deviation for the same. (eg: fasting restrictions of at least 10 hours before receiving the study drug?).

NOT OK

If the fasting condition is not maintained either at least 10 hours before dose or at least 4 hours post dose is a major deviation and your study might be questionable.

Regards
Raghavender.Chenna