Bioequivalence and Bioavailability Forum

Dear All,

My question is related to method validation which is intended to patient based PK study. Is it required to perform any of the method validation experiment (selectivity and matrix effect) by using patient biological matrix?

I am asking this because I feel that if some thing happen abnormally during study and we need to investigate the same then the evaluation of such kind of experiment may give us some light during investigation.

Regards

Auditor