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RegisterExclusion of Outlier Data [Outliers]
Dear Mr Suraj,
As per Health Canada Guidance Document on Conduct and Analysis of Comparative Bioavailability Studies "No more than 5% of the subjects may be considered to be outliers, unless there are 20 or fewer subjects. In your case, more than 5% of subjects are falling under the category of outliers.
Also, Re‐testing of subjects identified as outliers is not recommended as per Health Canada".
❝ 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.
As per Health Canada Guidance Document on Conduct and Analysis of Comparative Bioavailability Studies "No more than 5% of the subjects may be considered to be outliers, unless there are 20 or fewer subjects. In your case, more than 5% of subjects are falling under the category of outliers.
Also, Re‐testing of subjects identified as outliers is not recommended as per Health Canada".
—
Dr S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.
Dr S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.
Complete thread:
- Exclusion of Outlier Data surajpatel 2021-05-27 08:14
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Exclusion of Outlier Datadrgunasakaran1 2021-05-27 08:58
- Health Canada: read the guidance Helmut 2021-05-27 10:14
Ing. Helmut Schütz