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RegisterOutlier in a BE study [Outliers]
Hello to all,
We have conducted the pivotal study. In that one subject is showing different profile from rest of all. We have identified that subject as an outlier from Lund's test. By including that subject in statistical analysis study is not meeting BE criteria and excluding that subject study is meeting all BE criteria.
Now how to present this data to regulatory (including and excluding outlier or just excluding)?
whether regulatory accepts the such these type of data with outliers? Please explain the about these as early as possible.
Regards,
Auditor
We have conducted the pivotal study. In that one subject is showing different profile from rest of all. We have identified that subject as an outlier from Lund's test. By including that subject in statistical analysis study is not meeting BE criteria and excluding that subject study is meeting all BE criteria.
Now how to present this data to regulatory (including and excluding outlier or just excluding)?
whether regulatory accepts the such these type of data with outliers? Please explain the about these as early as possible.
Regards,
Auditor
Complete thread:
- Outlier in a BE studyauditor 2013-11-14 10:38
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Outlier in a BE study Dr_Dan 2013-11-14 14:41
- Outlier in a BE study Erkin 2014-01-21 19:21
- Outliers: reasons to not analyse? mittyri 2014-01-30 20:14
- I wouldn’t do that Helmut 2014-02-06 02:35
- Outliers: reasons to not analyse? mittyri 2014-01-30 20:14
- Outlier in a BE study Erkin 2014-01-21 19:21
- Outlier in a BE study jag009 2013-11-15 22:06
- Outlier in a BE study riteshsrmc 2014-01-16 12:44
- Outlier in a BE study Helmut 2014-01-16 14:54
- Outlier in a BE study luvblooms 2014-01-27 09:11
- Outlier in a BE study Dr_Dan 2013-11-14 14:41
Ing. Helmut Schütz