Bioequivalence and Bioavailability Forum

Dear Members,

In Bioanalytical Method Validation - Guidance for Industry - May 2018, For Selectivity parameter one of the acceptance criteria is mentioned as “Blank and zero calibrators should be free of interference at the retention times of the analyte(s) and the IS”.

Which means? Should we run Selectivity samples with calibrators?

Practice is after Specificity and Selectivity, pooling of matrix lots and spiking of calibrators and quality control samples.

Please opine.

Thanks & regards,
Avinash Jain M V

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Edit: Category changed; see also this post #1. [Helmut]