Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Back to the forum  2018-06-20 07:49 CEST (UTC+2h)

Extended release dosage form BE design [Design Issues]

posted by ssussu - China, 2017-08-29 11:38  - Posting: # 17748
Views: 1,015

Dear all,
According to the FDA guidance for Mirabegron extended release tablets, there are 3 studies included. Why the study of 25mg strenth under fed condition dose not need?
Additionally, about a extended release drug,if the half life is very long e.g. 70hr,dose the AUC truncte to AUC0-72h?
Is there guidance for extended release drug specially from FDA?

Please kindly give me some advice. Thank you!

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,395 posts in 3,909 threads, 1,174 registered users;
online 33 (0 registered, 33 guests [including 23 identified bots]).

The analysis of variance is not a mathematical theorem,
but rather a convenient method of arranging the arithmetic.    R.A. Fisher

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