Rules acc. to Health Canada [Outliers]
Hello everybody and nobody.
I'm just thinking about another slightly related issue.
Assume that there is an outlier in the study for Health Canada.
If the outlier wasn't removed, we would get GMR1, intra-subject CV1 and corresponding 90% CI.
However the outlier is removed according to the study protocol and the results are different:
Assume the border case with true GMR 0.8 and intra-subject CV e.g. 30%. The TIE (in the border case equal to power) in standard 2x2 BE is 5%. However I am not sure if it is the same with exclusion of outlier. So do we get some bonus power as intra-subject CV will be always lower after exclusion? I just imagine the simulation - individual simulated cases with:
Maybe someone could try to simulate it - TIE with the exclusion of outlier(s) for BE in 2x2.
I am not familiar with outliers and complicated simulations - simulate data (true GMR 0.8 and intra-subject CV 30%), look for outliers and exclude them (it could end with lowering the intra-subject CV), calculate 90% CI, and do it million times. The result will be probably close to 5%, but still higher?
Best regards,
zizou
I'm just thinking about another slightly related issue.
Assume that there is an outlier in the study for Health Canada.
If the outlier wasn't removed, we would get GMR1, intra-subject CV1 and corresponding 90% CI.
However the outlier is removed according to the study protocol and the results are different:
- GMR T/R can be higher or lower than GMR1 randomly.
- intra-subject CV will be always lower than intra-subject CV1.
Assume the border case with true GMR 0.8 and intra-subject CV e.g. 30%. The TIE (in the border case equal to power) in standard 2x2 BE is 5%. However I am not sure if it is the same with exclusion of outlier. So do we get some bonus power as intra-subject CV will be always lower after exclusion? I just imagine the simulation - individual simulated cases with:
- observed GMR lower or equal to 0.8 - the same as standard 2x2, i.e. not bioequivalent cases.
- observed GMR is higher than 0.8 - as observed intra-subject CV is lower in cases with the exclusion of outlier(s) - there will be slightly more bioequivalent cases than in standard 2x2 without exclusion of outlier(s).
Maybe someone could try to simulate it - TIE with the exclusion of outlier(s) for BE in 2x2.
I am not familiar with outliers and complicated simulations - simulate data (true GMR 0.8 and intra-subject CV 30%), look for outliers and exclude them (it could end with lowering the intra-subject CV), calculate 90% CI, and do it million times. The result will be probably close to 5%, but still higher?
Best regards,
zizou
Complete thread:
- Rules acc. to Health Canada Helmut 2019-02-05 15:04 [Outliers]
- 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 Canada Shuanghe 2019-02-06 11:48
- Rules acc. to Health Canada ElMaestro 2019-02-06 12:20
- Rules acc. to Health Canadazizou 2019-02-06 20:52
- Great post! Helmut 2019-02-07 10:37
- Rules acc. to Health Canada ElMaestro 2019-02-05 15:30