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RegisterExclusion of Outlier Data [Outliers]
Hi,
We completed fasting bioequivalence study for Health Canada with 28 subjects. 4 subjects are showing outliers (more than 10 times of Cmax from other subjects). Can we exclude these subjects and submit the data to Health Canada. Will they accept after exclusion because the study fails if we include those 4 outliers data or we need to go for re-dosing those 4 subjects and submit the new data. Thanks.
Suraj
We completed fasting bioequivalence study for Health Canada with 28 subjects. 4 subjects are showing outliers (more than 10 times of Cmax from other subjects). Can we exclude these subjects and submit the data to Health Canada. Will they accept after exclusion because the study fails if we include those 4 outliers data or we need to go for re-dosing those 4 subjects and submit the new data. Thanks.
Suraj
Complete thread:
- Exclusion of Outlier Datasurajpatel 2021-05-27 08:14
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Exclusion of Outlier Data drgunasakaran1 2021-05-27 08:58
- Health Canada: read the guidance Helmut 2021-05-27 10:14
Ing. Helmut Schütz