Subject exclusion [Outliers]

posted by Ohlbe – France, 2018-10-02 21:30 (876 d 07:15 ago) – Posting: # 19396
Views: 4,694

Dear Mohamed,

» My question is: when we calculate the geometric mean of the reference auc, shall we include the subject we want to inspect in the calculation of the geometric mean or we shall remove it first before making the calculation?

The guideline is clear on this point:
A subject is considered to have very low plasma concentrations if its AUC is less than 5% of reference medicinal product geometric mean AUC (which should be calculated without inclusion of data from the outlying subject).

Regards
Ohlbe

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