Bioequivalence and Bioavailability Forum 17:52 CET

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Subject exclusion [Outliers]

posted by Mohamed Yehia - Egypt, 2018-10-02 21:25  - Posting: # 19395
Views: 1,620

Hi All,

Concerning what stated in EMEA guidelines, if auc of reference cmax of certain subject is less than 5% of the geometric mean, the subject is excluded.

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?

Thanks.


Edit: Category changed; see also this post #1[Helmut]

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