Bioequivalence and Bioavailability Forum

Dear nvs!

❝ I would like to know the Scientific reason for evaluating the hemolyzed &

❝ lipemic samples in the selectivity of validation.

I assume you are referring to Brazil's (ANVISA) regulation?

It's good practice to record the state of the plasma sample, preferably during in the clinical part of the study, but at least during sample preparation in bioanalytics.
If a particular sample shows an 'irregular' result (problems in extraction, interferences in chromatography, etc.) and it was documented as hemolytic/lipemic, you will have good arguments to exclude this data point from the PK-evaluation.

Now a little bit about the rationale:
If you have included such samples in validation, you simply know whether hemolytic and/or lipemic conditions do influence the performance (accuracy/precision) of the method; otherwise you may only guess so.