Parent Drug and Active Metabolite [Regulatives / Guidelines]

posted by joyjac – Philippines, 2006-05-09 07:45  – Posting: # 120
Views: 7,408

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:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,880 posts in 4,214 threads, 1,364 registered users;
online 7 (1 registered, 6 guests [including 3 identified bots]).
Forum time (Europe/Vienna): 00:08 CEST

Competence, like truth, beauty and contact lenses,
is in the eye of the beholder.    Laurence J. Peter

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