Bioequivalence and Bioavailability Forum

❝ But we are in search of the reference for second dose pre and post dose diet restriction.

Dear Mr Pradeep Labana,

EMA does not specify about fasting criteria for Evening dose and Evening post dose restrictions period in their Bioequivalence Guidance. Practically, it is not possible and feasible to maintain the same 08 hours fasting criteria and 04 hours post dose food restriction after evening dose in case of Multiple dose studies.

Whereas, FDA's Old BE Guidance states that "The evening dose should be administered after a fast of at least 2 hours and subjects should continue fasting for 2 hours post-dose" and CDSCO's BE Guidance also states that "For multiple dose fasting studies, when a evening dose must be given, two hours of fasting before and after the dose is considered acceptable".

You can maintain the same 02 hours fasting prior to evening dose and 02 hrs post dose fasting criteria after the Evening dose for EMA submission which will be generally acceptable.