Primidone BE study for USFDA submission [Regulatives / Guidelines]

posted by jag009  – NJ, 2018-04-09 18:16 (2498 d 08:29 ago) – Posting: # 18656
Views: 4,338

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
23,376 posts in 4,912 threads, 1,662 registered users;
241 visitors (0 registered, 241 guests [including 16 identified bots]).
Forum time: 01:45 CET (Europe/Vienna)

Science is what you know.
Philosophy is what you don’t know.    Bertrand Russell

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