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Registerphase 4 safety study of Furazolidone [Design Issues]
Dear kardambhatt
as far as I know furazolidone is not systemic available and consequently a bioequivalence study based on bioavailability will not be possible (but this is the main focus of this forum). However, as you said you plan a phase IV study but I am not sure what the aim of this study should be since your product is already registered and market which implies that safety and efficacy have already been shown. Do you want to monitor adverse events?
Kind regards
Dr_Dan
as far as I know furazolidone is not systemic available and consequently a bioequivalence study based on bioavailability will not be possible (but this is the main focus of this forum). However, as you said you plan a phase IV study but I am not sure what the aim of this study should be since your product is already registered and market which implies that safety and efficacy have already been shown. Do you want to monitor adverse events?
Kind regards
Dr_Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- phase 4 safety study of Furazolidone kardambhatt 2014-05-05 09:07
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- phase 4 safety study of FurazolidoneDr_Dan 2014-05-07 07:59
- phase 4 safety study of Furazolidone kardambhatt 2014-05-07 13:10
- phase 4 safety study of FurazolidoneDr_Dan 2014-05-07 07:59
Ing. Helmut Schütz