Statistical Outlier Detection

[anil]

Hi,
Pl help me in detecting outlier/inconsistent value of AUC & CMAX in BE study with 14 subjects

[deleted_user]

You can use Lund's test which is approved by the USFDA for the outlier detection.
You can refer bolton's book for the same the sas code is also given there.

[anil]

Thanks for the reference.

Is it necessary to apply statistical test to detect outliers in BA/BE studies for submission to USFDA?

I have found very few statisticians applying the test for 'outliers' (even if CV >30%)., some times they delete the volunteer from statistical analysis.

Experts pl offer help to resolve this issue.

Thanks

Anil