Bioequivalence and Bioavailability Forum

Dear Auditor,

❝ 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.

Please understand purpose of that CRO for this activity first. From my point of view intension behind this to prepare thease QC samples for dilution integrity. Which can be used during repeat sample analysis of dilution integrity identified samples (Samples showing concentration above ULOQ)

In validation they may be confirmed it's suitability by proving accuracy & precision.

Procedure may be as per follow....................
- Prepare QC (having concentration higher than ULOQ)
- Dilute it appropriately (2 times/ 4 times)
- Confirmed it's precision and accuracy in method vaidation
- In repeat analysis of samples having values above ULOQ, dilute identified repeat sample and these QC samples and run the batch.
- Use all values after using dilution factor.

❝ 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.

In such analysis you have to dilute those sample appropriately which tends to provide concentration in CC range only. But for reporting purpose you have to use dilution factor.

These type of QCs are very useful for validating results which are above the CC range found during study sample analysis.

Please revert back if this justification is suitable from your side or you want more details on this exercise.

Regards,
Swapnil D. Kuche