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RegisterRe-dosing study of outlier in BA/BE studies [Design Issues]
Hi,
suppose if i conduct two way crossover BA/BE study in 60 subjects, out of this 60 subjects, if 1 subject is considered outlier as per analytical data.
How can we plan redosing study in 10 subjects including anamolus?
If anamolous subject gets the same concentration data as same as previous study, what should be done with study results?
Or is there any provision for outlier in any guideline?
suppose if i conduct two way crossover BA/BE study in 60 subjects, out of this 60 subjects, if 1 subject is considered outlier as per analytical data.
How can we plan redosing study in 10 subjects including anamolus?
If anamolous subject gets the same concentration data as same as previous study, what should be done with study results?
Or is there any provision for outlier in any guideline?
Complete thread:
- Re-dosing study of outlier in BA/BE studiesharrypotter_1234567 2010-11-23 12:53
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Re-dosing study of outlier in BA/BE studies Helmut 2010-11-23 14:14
Ing. Helmut Schütz