Bioequivalence and Bioavailability Forum

Hello Friends,

Hope all are doing well....

As per the new Bioanalytical Method validation guidelines, "Study samples with concentrations listed below the LLOQ should be reported as below the LLOQ (BQL). Study samples with concentrations above the ULOQ should be diluted and re-analyzed, or the standard curve should be extended and revalidated."

This means, whether we have to replace BQL values with "zero" or can we keep as it is in the BE analysis without replacing those values with zero?

We have a situation that, one of our study is passing the BE with BQL values (without replacing those values with zero), but failed to attain the BE without BQL values(with replacing those values with zero).