Bioequivalence and Bioavailability Forum

Dear friends,

❝ BTW, according to the short average gastric emptying time of water in the stomach (15 minutes, see references), differences in volume would quickly level out anyway.

Considering this, what could be the variation that can be considered 'allowable' for various agencies (e.g. ANVISA)? For instance, Some investigator might have given 200 mL of water, but her/his measuring cylinder might not have been calibrated and/or would have been of plastic (increasing risk of variation with temperature). Should this be a cause of concern to the clinical team (CRO/sponsor)?

I presume a QA personnel may want cylinder to be calibrated to ensure no variance (or known variance) and contrarily, PK personnel may justify that it'd hardly make a difference; but from a regulatory submission point of view, I wonder what could be the best choice.

This may be too much thinking, but I guess it's good to think if big projects are at stake.

requesting your kind responses on this,

regards,
Kshitij