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RegisterFurosemide 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 It is listed in FDA draft guidance that it is not high variable drug and i can use 2 way crossover design.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 ?
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 It is listed in FDA draft guidance that it is not high variable drug and i can use 2 way crossover design.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:
- Furosemide oral tabletIbrahim Komeil 2019-11-18 09:03 [Regulatives / Guidelines]
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Ing. Helmut Schütz