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Dear myy
In order to possibly give you some advice more information would be needed. I guess the study was conducted in humans, right? And the AUC was truncated due to the long terminal half life of the drug? Comparative dissolution showed f2 values >50 at all three pH levels (1.2, 4.5 and 6.8)? The high ANOVA CV was not caused by outlying subjects? Before you start reformulating your product you need to be sure that the study outcome is valid.
Kind regards
Dr_Dan
In order to possibly give you some advice more information would be needed. I guess the study was conducted in humans, right? And the AUC was truncated due to the long terminal half life of the drug? Comparative dissolution showed f2 values >50 at all three pH levels (1.2, 4.5 and 6.8)? The high ANOVA CV was not caused by outlying subjects? Before you start reformulating your product you need to be sure that the study outcome is valid.
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:
- Failed study myy 2014-03-07 16:19
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- No sample size estimation in protocol? Helmut 2014-03-07 16:47
- No sample size estimation in protocol? myy 2014-03-08 21:32
- Failed study ElMaestro 2014-03-07 17:20
- Failed study nobody 2014-03-07 18:02
- Failed study myy 2014-03-08 21:40
- Failed study Dr_Dan 2014-03-10 17:36
- Failed studyDr_Dan 2014-03-07 19:21
- Failed study myy 2014-03-08 22:04
- Failed study Dr_Dan 2014-03-10 17:44
- Failed study myy 2014-03-08 22:04
- No sample size estimation in protocol? Helmut 2014-03-07 16:47
Ing. Helmut Schütz