Subject exclusion [Outliers]

posted by Ohlbe – France, 2018-10-02 19:46 (753 d 18:51 ago) – Posting: # 19399
Views: 4,411

Dear Mohamed,

» [...] will that subject be included in the outlier calculation or I shall remove it first , then calculate outlier of the rest of volunteers and check if there is outlier or not and then calculate geometric mean?

The guideline does not ask for any statistical outlier test to be performed. If you have a subject with very low concentrations, calculate the geometric mean of the AUC of the reference without that subject. If the AUC of the subject for the reference product is lower than 5 % of that mean you have a possibility to exclude him. That's all.

Regards
Ohlbe

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