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RegisterRules acc. to Health Canada [Outliers]
Dear all,
On slightly related issue. Canadian guideline says max 5% outliers can be removed and one criterion for outlier test is studentised residual > 3.
I had an incidence in a pilot study where there are more than 5% subjects having studentised residual > 3. Since it's a pilot, it doesn't matter too much but in the protocols of pivotal studies I made it very clear that if this happens, the 5% subjects to be removed will be chosen by the magnitude of the residuals: only remove those with highest residual (in absolute value, e.g., those with residual -7 will be removed before those with residual 5). For the rest of those subjects, even though they are identified as outlier, they will be included in the BE evaluation, in accordance with guidance's 5% rule. Unfortunately (or fortunately), it never happens to my pivotal studies so I have no idea if Canadian agency is really ok with this.
Do any of you have such experience?
On slightly related issue. Canadian guideline says max 5% outliers can be removed and one criterion for outlier test is studentised residual > 3.
I had an incidence in a pilot study where there are more than 5% subjects having studentised residual > 3. Since it's a pilot, it doesn't matter too much but in the protocols of pivotal studies I made it very clear that if this happens, the 5% subjects to be removed will be chosen by the magnitude of the residuals: only remove those with highest residual (in absolute value, e.g., those with residual -7 will be removed before those with residual 5). For the rest of those subjects, even though they are identified as outlier, they will be included in the BE evaluation, in accordance with guidance's 5% rule. Unfortunately (or fortunately), it never happens to my pivotal studies so I have no idea if Canadian agency is really ok with this.
Do any of you have such experience?
—
All the best,
Shuanghe
All the best,
Shuanghe
Complete thread:
- Rules acc. to Health Canada Helmut 2019-02-05 15:04
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Rules acc. to Health Canada ElMaestro 2019-02-05 15:30
- Rules acc. to Health Canada Helmut 2019-02-05 16:24
- Rules acc. to Health Canada ElMaestro 2019-02-05 17:33
- Rules acc. to Health Canada Helmut 2019-02-05 16:24
- Rules acc. to Health Canada Ohlbe 2019-02-05 15:54
- Rules acc. to Health Canada Helmut 2019-02-05 17:52
- for either the test or reference product? mittyri 2019-02-05 15:58
- Discordant outliers Helmut 2019-02-05 17:42
- Rules acc. to Health CanadaShuanghe 2019-02-06 11:48
- Rules acc. to Health Canada ElMaestro 2019-02-06 12:20
- Rules acc. to Health Canada zizou 2019-02-06 20:52
- Great post! Helmut 2019-02-07 10:37
- Rules acc. to Health Canada ElMaestro 2019-02-05 15:30
Ing. Helmut Schütz