Mithu
☆    

India,
2019-07-22 13:07

Posting: # 20422
Views: 440
 

 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
Activity
 Admin contact
20,253 posts in 4,262 threads, 1,398 registered users;
online 14 (1 registered, 13 guests [including 5 identified bots]).
Forum time (Europe/Vienna): 20:26 CET

Statistics is, or should be, about scientific investigation
and how to do it better, but many statisticians believe
it is a branch of mathematics.    George E.P. Box

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