Bioequivalence and Bioavailability Forum

Hi John,

» Do you know why some sponsors want to have their samples kept until application approved?

"Because we've always done it", I guess...

» From EMA or FDA, is there a requirement mentioned in any of the guidances?

EMA: no. FDA: not that I know of.

» We are doing this (store samples) as well and I wonder why we need to if the age of the samples exceeds the long term stability date.

I agree with ElMaestro: some sponsors just want to be on the safe side and only repeat the bioanalytical part rather than the whole study if the lab messed up somewhere. There was a time also when guidelines or requirements were not as clear as they can be now and an Agency would unexpectedly ask for the metabolite in addition to the parent, or similar stuff.