Bioequivalence and Bioavailability Forum

Dear ksreekanth,

❝ Hi i need clarity regarding Reinjection Reproducibility (RR) experiment which is performed during Bioanalytical method validation. I have observed two kinds of approaches [...]

❝ Kindly clarify whether the check point is reproducibility of QC results with Initial CC as well as reinjected CC (Approach 1) or the stability of reinjected QC samples under fresh CC (Approach 2). Which approach to be followed and established during method validation so as to mimic reinjection conditions due to system stoppages encountered during study sample analysis.

Well, what do you plan to do if you have to re-inject part of the samples during your study because of an instrument failure in the middle of the run: will you refer to the initial calibration curve (Approach 1), or prepare a fresh calibration curve and analyse the old samples against a fresh curve (Approach 2) ?

So how do you think you should proceed during your validation ?