Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-09-23 21:54 CEST (UTC+2h)
 
ssussu
Junior

China,
2017-08-29 11:38

Posting: # 17748
Views: 286
 

 Extended release dosage form BE design [Design Issues]

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!
Back to the forum Activity
 Thread view
Bioequivalence and Bioavailability Forum | Admin contact
17,323 Posts in 3,705 Threads, 1,071 registered users;
27 users online (0 registered, 27 guests).

It’s easy to lie with statistics;
it is easier to lie without them.    Frederick Mosteller

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