Rules acc. to Health Canada [Outliers]

posted by Ohlbe – France, 2019-02-05 16:54 (1960 d 19:35 ago) – Posting: # 19870
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Dear Helmut,

❝ Do I understand the guidance correctly: I’m not allowed to exclude the pAUC of the outlying subject cause the other metrics are fine?


Interesting. Well, pAUC was added to the guidance in June 2018, but the section on outliers was already there. Not sure that they considered all implications when they revised the guidance. Maybe it would be worth contacting Health Canada to ask for a confirmation ? They may have only had Cmax and AUCt in mind when this paragraph was written ?

Regards
Ohlbe

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