Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Back to the forum  2018-07-23 17:33 CEST (UTC+2h)

Primidone BE study for USFDA submission [Regulatives / Guidelines]

posted by jag009 - NJ, 2018-04-09 16:16  - Posting: # 18656
Views: 781

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:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,547 posts in 3,941 threads, 1,190 registered users;
online 15 (0 registered, 15 guests [including 12 identified bots]).

[The] impatience with ambiguity can be criticized in the phrase:
absence of evidence is not evidence of absence.    Carl Sagan

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed