Statistical Outlier Detection

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Contributor
Posts: 26

Statistical Outlier Detection

Hi,
Pl help me in detecting outlier/inconsistent value of AUC & CMAX in BE study with 14 subjects
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Posts: 0

Re: Statistical Outlier Detection

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.
Contributor
Posts: 26

Re: Statistical Outlier Detection

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
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