Bioequivalence and Bioavailability Forum

Hey LB,

❝ There was one more observation in one of the study for Canada Market

❝ Out of 72 volunteer 2 showed 0 absorption for reference!!!

❝ Looks like buggers threw the formulations away!!

❝

❝ Though the study is passing with and without those volunteers and we have decided to submit the same to the Health Canada.

❝

❝ But I would like to ask that in such condition, how one should handle it?

❝ Any suggestion??

If I understand you correctly, in two cases you have a series of BLQ and that would be highly unexpected. Given what you know about the assay, the formulations, the metabolism, the genetics, is it plausible to see 2 flat lines in the study if the subjects were properly dosed, sampled and analysed? It shouldn't be.
This is a case where you could do a for-cause audit. Look with your own eyes and ask the difficult questions to see if you can identify a root cause, and to evaluate if you would use the same CRO again.