Bioequivalence and Bioavailability Forum

Dear Auditor,

❝ I have observed one procedure which is followed by one of the CRO during validation.

❝ Calibration range is: 50 to 1200 ng/ ml

❝ ULOQ QC concentration is: 1215 ng/ ml.

Unless this is a LBA method, the use of a ULOQ QC sample is not mandatory (though it has been recommended by some people, see the overview of comments on the EMA BMV guideline).

❝ 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.

You said they are doing this in the method validation: meaning that the range of concentrations which can be measured has not been established yet (that's precisely what they are trying to do). The idea of using a ULOQ sample is to demonstrate that you have an acceptable precision and accuracy throughout your measurement range. As such, I am not shocked to see a ULOQ QC 1 % above the upper limit of the calibration curve.

Of course, having the same QC sample during study sample analysis would raise more questions.

Regards
Ohlbe