Primidone BE study for USFDA submission [Regulatives / Guidelines]

posted by jag009  – NJ, 2018-04-09 16:16 (1632 d 17:18 ago) – Posting: # 18656
Views: 3,459

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
22,391 posts in 4,685 threads, 1,595 registered users;
online 7 (0 registered, 7 guests [including 6 identified bots]).
Forum time: Wednesday 09:35 CEST (Europe/Vienna)

The real struggle is not between the right and the left
but between the party of the thoughtful
and the party of the jerks.    Jimmy Wales

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