Mithu
★    

India,
2019-07-22 15:07
(1711 d 02:25 ago)

Posting: # 20422
Views: 1,633
 

 Major metabolite fortification [Bioanalytics]

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
UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,638 registered users;
76 visitors (0 registered, 76 guests [including 8 identified bots]).
Forum time: 16:33 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5