Replicate Study designs [Outliers]
Dear All,
We have small statistical problem in one BE partial replicate study data, and this study having 48 subjects data with this data BE acceptance criteria is not meeting due to two subject showing low concentrations
Subject I-Test has shown low concentration (1/10 times) when compared with Reference formulations (R1&R2).
Subject II-one Reference has shown low concentration (1/10 times) when compared with test & other Reference formulation.
If we are excluding these two subjects, variability observed is<30% and met the 90% CI.
If we are including these two subject, variability observed is >30% and not met the 95% bound.
So, how can we justify those two subjects data as outliers/anomalous and how to perform statistical analysis in such a case?
Please clarify
Edit: Category changed. [Helmut]
We have small statistical problem in one BE partial replicate study data, and this study having 48 subjects data with this data BE acceptance criteria is not meeting due to two subject showing low concentrations
Subject I-Test has shown low concentration (1/10 times) when compared with Reference formulations (R1&R2).
Subject II-one Reference has shown low concentration (1/10 times) when compared with test & other Reference formulation.
If we are excluding these two subjects, variability observed is<30% and met the 90% CI.
If we are including these two subject, variability observed is >30% and not met the 95% bound.
So, how can we justify those two subjects data as outliers/anomalous and how to perform statistical analysis in such a case?
Please clarify
Edit: Category changed. [Helmut]
Complete thread:
- Replicate Study designsbalakotu 2014-01-08 08:14 [Outliers]
- Replicate Study designs Dr_Dan 2014-01-08 09:54
- Replicate Study designs Mahesh M 2014-01-08 13:18
- Replicate Study designs Dr_Dan 2014-01-08 15:24
- Replicate Study designs jag009 2014-01-08 15:33
- Re-testing Helmut 2014-01-08 16:16
- Replicate Study designs Dr_Dan 2014-01-08 15:24
- Replicate Study designs Mahesh M 2014-01-08 13:18
- Replicate Study designs Ohlbe 2014-01-08 14:24
- Replicate Study designs Dr_Dan 2014-01-08 09:54