Bioequivalence and Bioavailability Forum

Hi shreyas goswami,

❝ Is it acceptable to incorporate additional QC on the basis of AVG Cmax of analyzed subjects. or it should be evaluated by the concentration data of each period separately?????

Rather than thinking in terms of periods, I prefer to shift the focus to runs per se:
For every run you look at the QC response for the second set, and there should be unknowns (=PK-samples) falling above that QC level. Then the QC levels are well chosen.

If a run suddenly has all unknowns below the second QC level, then then right there is an issue you can nominate as a "risk", and thus it is time for a time-out and and update of the QC-levels. You might add a QC level somewhere between first and second level, depending on the actual observations in the run in question but with an eye also towards concentrations in the previous runs.