Outlier in a BE study [Outliers]

posted by auditor – India, 2013-11-14 11:38 (3871 d 07:40 ago) – Posting: # 11884
Views: 11,436

Hello to all,

We have conducted the pivotal study. In that one subject is showing different profile from rest of all. We have identified that subject as an outlier from Lund's test. By including that subject in statistical analysis study is not meeting BE criteria and excluding that subject study is meeting all BE criteria.

Now how to present this data to regulatory (including and excluding outlier or just excluding)?
whether regulatory accepts the such these type of data with outliers? Please explain the about these as early as possible.

Regards,
Auditor

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