Rules acc. to Health Canada [Outliers]

posted by Helmut Homepage – Vienna, Austria, 2019-02-05 17:52 (803 d 14:09 ago) – Posting: # 19875
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Hi Ohlbe,

» […] 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 ?

Maybe. This part of (3) is funny:

Parameters of interest are usually an AUC and Cmax measure, but in some instances other parameters are required.

Others? Wow! I guess they mean additional ones. The only studies I ever have done without AUC and Cmax were for an antibiotic where primary were a set of Occupany times. ;-)
And yes, we are in constant contact with HC. This part slipped through my attention.

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