Bioequivalence and Bioavailability Forum

Hi John,

Yes, that's what I wrote in my post: it makes little sense to keep the samples if you don't have the long-term stability data to back this up.

A solution could be to also keep QC samples along with the study samples, to be able to check the long-term stability in case you need some re-analysis. But this won't help if you have to re-analyse the samples for another analyte such as a metabolite.

Most CROs charge for sample storage after 3 to 6 months, which usually makes sponsors reconsider their "just-in-case" attitude