Furosemide oral tablet [Regulatives / Guidelines]

posted by Ibrahim Komeil – Egypt, 2019-11-18 10:03 (1177 d 06:26 ago) – Posting: # 20818
Views: 1,093

Dear all

I would like to ask about bioequivalence study for Furosemide oral tablet. It is listed in FDA draft guidance that it is not high variable drug and i can use 2 way crossover design. However, i read EMA guidelines and MHRA guidelines assure its high interasubject variability so they recommend to have partial replicated design applying normal acceptance range (80%-125%), so what do you think about these data upon on your experience ?

Complete thread:

UA Flag
 Admin contact
22,485 posts in 4,710 threads, 1,603 registered users;
18 visitors (0 registered, 18 guests [including 7 identified bots]).
Forum time: 16:29 CET (Europe/Vienna)

The difference between a surrogate and a true endpoint
is like the difference between a cheque and cash.
You can get the cheque earlier but then,
of course, it might bounce.    Stephen Senn

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