Bioequivalence and Bioavailability Forum

Hi..

We are writing a SOP for Bioanalytical method validation.

As per US FDA's guideline on Bio analytical method validation "Recovery experiments should be performed by comparing the analytical results for extracted samples at three concentrations (low, medium, and high) with unextracted standards that represent 100% recovery"

During validation we demonstrate QCs at HQC, MQC1, MQC2 (lower conc. than MQC1), LQC levels.

Now my doubt is if an additional QC (say MQC3 (lower conc. than MQC2)) is introduced into the run, so that the subject samples meet at least two levels of QCs as per EMEA's guideline recommendation, is there a chance that the regulator may ask us to demonstrate the recovery at that additional QC level also? Is a bracketing approach valid in this case?

Regards
P.S.Srinivas

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Edit: Category changed. [Helmut]