Posting: # 19595
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.
Thanks & regards,
Avinash Jain M V
Edit: Category changed; see also this post #1. [Helmut]
Posting: # 19596
» Which means? Should we run Selectivity samples with calibrators?
Not necessarily a full calibration curve, but at least samples spiked at the LLOQ, so that you can compare the signal in the blanks to the signal at the LLOQ.
Posting: # 19599
Thank you for the response.