Bioequivalence and Bioavailability Forum

Hi Dr_Dan,


it is a tricky question. On whom is the burden of proof here?

I would perhaps try and argue that since the excipient is common, used for decades, generally allowed and since PRAC and CHMP and SWP and so forth did not in any way indicate the need for a review of safety/potential toxicity etc., the excipient should be considered ok.
At the end of the day the purpose of the regulatory mechanisms is to capture those things since they have access to much more info then you/we have. Their analysis is potentially much more sensitive than anything you can look into or speculate into.

Absence of evidence vs evidence of absence...