Ibrahim Komeil
☆    

Egypt,
2019-11-18 09:03

Posting: # 20818
Views: 362
 

 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 It is listed in FDA draft guidance that it is not high variable drug and i can use 2 way crossover design.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 ?
Activity
 Admin contact
20,121 posts in 4,245 threads, 1,383 registered users;
online 8 (2 registered, 6 guests [including 4 identified bots]).
Forum time (Europe/Vienna): 03:35 CET

Genius is that which forces
the inertia of humanity to learn.    Henri Bergson

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