Rules acc. to Health Canada [Outliers]

posted by ElMaestro  – Denmark, 2019-02-05 15:30 (860 d 12:54 ago) – Posting: # 19868
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Hi Helmut,

yes it was meant to indicate that if one metric is outlier then the others should be as well before exclusion is appropriate. However, I don't think they are always enforcing it that way. After all, rate is not the same as extent and vice versa.

But does it make a big difference? Exclusion changes little in your case since it was a pilot and you will need to consider the sample size and relevance of the CV and PE sampled in the pilot when planning the pivotal in any case.

If Cmax and AUC were more or less normal for the subject, then in all likelihood she munched the medication as directed to and what you saw is populations , products and random happenings at work.

Pass or fail!
ElMaestro

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