Bioequivalence and Bioavailability Forum

Dear Joshi,

❝ At the time of validation if matrix used is a mimic of samples to be analyzed

This would mean that you would be performing your validation with samples from a previous study ? Basically, you would be doing this incurred samples re-analysis for one study, and using this for other studies on the same drug. Difficult to say if the FDA (as far as I know, they are the only ones asking for incurred samples re-analysis so far) would accept it or not: they have not incorporated this into a guideline so far. But from what I have heard of the AAPS meeting on incurred samples reanalysis last February or March, they were willing to ask for it for each and every BE trial. They might accept it for other kind of trials.

Don't pretend to "mimic" real samples another way. You would spend more time trying to convince the FDA that your samples are representative of study samples. One prerequisite would be that your drug has strictly no metabolite; other possible sources of variation would be more problematic to discuss.

Regards
Ohlbe