Parent Drug and Active Metabolite [Regulatives / Guidelines]

posted by joyjac – Philippines, 2006-05-09 09:45 (6349 d 08:09 ago) – Posting: # 120
Views: 9,924

FDA CDER Guidance states that if the parent drug can be measured, the confidence interval should be applied to the parent drug but data of the active metabolite must be submitted to provide evidence of comparable therapeutic outcome. Does this mean we need to calculate also the 90% CI for the active metabolite? What if the 90% CI for the parent drug falls within the BE limit but Not for the active metabolite? Highly appreciate your insight on this BE issue. Thanks.

Complete thread:

UA Flag
Activity
 Admin contact
22,761 posts in 4,775 threads, 1,628 registered users;
18 visitors (0 registered, 18 guests [including 6 identified bots]).
Forum time: 17:55 CEST (Europe/Vienna)

Whenever a theory appears to you as the only possible one,
take this as a sign that you have neither understood the theory
nor the problem which it was intended to solve.    Karl R. Popper

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