Primidone BE study for USFDA submission [Regulatives / Guidelines]

posted by jag009  – NJ, 2018-04-09 18:16 (1813 d 07:34 ago) – Posting: # 18656
Views: 3,500

Haven't looked up the drug but are both metabolites active? To be on the safe side (if you don't want to file control correspondence) then i would measure the active metabolites since FDA usually ask to have the data collected.

John

Complete thread:

UA Flag
Activity
 Admin contact
22,555 posts in 4,724 threads, 1,606 registered users;
18 visitors (0 registered, 18 guests [including 12 identified bots]).
Forum time: 01:50 CEST (Europe/Vienna)

Learning of many things
does not teach intelligence.    Heraclitus of Ephesus

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