Bioequivalence and Bioavailability Forum

Dear Dixit!

❝ How to maintain the water restriction 1 hour pre dose and 1 hour Post dose..

This restriction is stated in some (not all!) general guidelines. As all guidelines, they may be inadequate for a given drug/regimen. See here. If in your specific situation something is justifiable based on clinical grounds, fine. The protocol has to pass the IEC/IRB and the competent authority anyhow. If they don’t like it, they will tell.

❝ Please guide me with relevant literature

Examples are antidiabetics (where a dextrose solution is administered either together with the study drug or even every 15 minutes post dose). See this post.