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kardambhatt ☆ India, 2014-05-05 11:07 (4433 d 04:40 ago) Posting: # 12912 Views: 3,918 |
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heloo I wants to design protocol for phase 4 safety study of Furazolidone any one pls guide me Edit: Category changed. [Helmut] |
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Dr_Dan ★★ Germany, 2014-05-07 09:59 (4431 d 05:48 ago) @ kardambhatt Posting: # 12920 Views: 3,110 |
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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 — Kind regards and have a nice day Dr_Dan |
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kardambhatt ☆ India, 2014-05-07 15:10 (4431 d 00:37 ago) @ Dr_Dan Posting: # 12922 Views: 3,204 |
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Thanks Very Much Dr_Dan ❝ Do you want to monitor adverse events? Yes sir i am planning to monitor all AE associated with Furazolidone. Edit: Standard quotes restored. Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe] |
Ing. Helmut Schütz