Bioequivalence and Bioavailability Forum

Dear All,

I need your comment on the following.

I have observed one procedure which is followed by one of the CRO during validation. While preparing QC samples from second weight the prepared ULOQ QC concentrations is higher then the established ULOQ concentrations in calibration curve.

For more clarity kindly refer the followings:

Calibration range is: 50 to 1200 ng/ ml

ULOQ QC concentration is: 1215 ng/ ml.

I have object for such kind of estimation of ULOQ QC as it is not within the established CC range under which P&A samples were analyzed.

I need your suggestion regarding this and if possible can you please suggest me any guideline containing such kind of references. I have referred the entire available article pertinent to this but I could not get any information for the same.

Regards,

Auditor