Ibrahim Komeil
☆    

Egypt,
2019-11-18 09:03
(954 d 09:04 ago)

Posting: # 20818
Views: 1,046
 

 Furosemide oral tablet [Regulatives / Guidelines]

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 It is listed in FDA draft guidance that it is not high variable drug and i can use 2 way crossover design.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 ?
UA Flag
Activity
 Admin contact
22,181 posts in 4,647 threads, 1,572 registered users;
online 4 (0 registered, 4 guests [including 2 identified bots]).
Forum time: Wednesday 19:08 CEST (Europe/Vienna)

Nerds don’t just happen to dress informally.
They do it too consistently.
Consciously or not, they dress informally
as a prophylactic measure against stupidity.    Paul Graham

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5