Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2018-02-22 04:07 CET (UTC+1h)
 

Extended release dosage form BE design [Design Issues]

posted by ssussu - China, 2017-08-29 11:38  - Posting: # 17748
Views: 738

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
17,926 Posts in 3,816 Threads, 1,120 registered users;
29 users online (0 registered, 29 guests).

When people learn no tools of judgment
and merely follow their hopes,
the seeds of political manipulation are sown.    Stephen Jay Gould

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