Bioequivalence and Bioavailability Forum

Hello All,

During review of FDA document (SBOA) for specific products, some times it is observed that there is no active metabolite for respective analyte but there is a major metabolite found in reference document of NDA.

Here the question is, do we need to bother about major metabolite in our assay validation?

To overcome this situation, we have stared fortyfying such major metabolite with actual analyte and proven that the assay is not affected and there is no cause for any back conversion.

Recently we face the same in Sacubatril method validation. Now Innovator has come out with the Citizen Petition where they ask to measure the metabolite which is referred as major not an active.


please suggest, what should be followed now on wards,

1. it is better to measure major metabolite always?
2. Fortyficaiton would be sufficient?

Regards,

Mithu