Bioequivalence and Bioavailability Forum

Dear Farmacevt,

❝ Please advise what if the Lower limit of quantification for some of the subjects in the BE study is greater than 5% of Cmax (not for the pre-dose concentrations).

There is always possibility that few subjects may have LLOQ of more than 5% Cmax as during the method development, the assumed Cmax is higher(compared to lower Cmax in observed) in current case. If the subjects are more than 20% having 1st time point of more than 5% Cmax, then there could be an issue with your CC range, but if less than 20% – it is generally good to submit the dossier.
To prevent the scenario in future, kindly take a range of Cmax for consideration of CC range. The lower Cmax can be considered for 5 or 6 half life consideration of LLOQ and upper Cmax for ULOQ consideration.
Regards,
dshah