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RegisterOutlier in a BE study [Outliers]
Hi Auditor,
By the way to which agency you are filing the product? Agreed with Dan! EMEA has clearly defined the situation in guidance. I would suggest you to look at FDA perspective as well, if you are filing to FDA. FDA does not encourage redosing to handle outliers subjects incase of non-replicate design study wherein you may carry out redosing incase of replicate design. You should be clear they way agency look at the data with or without outliers.
By the way to which agency you are filing the product? Agreed with Dan! EMEA has clearly defined the situation in guidance. I would suggest you to look at FDA perspective as well, if you are filing to FDA. FDA does not encourage redosing to handle outliers subjects incase of non-replicate design study wherein you may carry out redosing incase of replicate design. You should be clear they way agency look at the data with or without outliers.
Complete thread:
- Outlier in a BE study auditor 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 studyriteshsrmc 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