Bioequivalence and Bioavailability Forum

Rules acc. to Health Canada [Outliers]

posted by Helmut  – Vienna, Austria, 2019-02-05 18:52 (2256 d 05:30 ago) – Posting: # 19875
Views: 8,997

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 C_max 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 C_max 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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Helmut Schütz


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Complete thread:

• Rules acc. to Health Canada Helmut 2019-02-05 15:04 
  • Rules acc. to Health Canada ElMaestro 2019-02-05 15:30
    • Rules acc. to Health Canada Helmut 2019-02-05 16:24
      • Rules acc. to Health Canada ElMaestro 2019-02-05 17:33
  • Rules acc. to Health Canada Ohlbe 2019-02-05 15:54
    • Rules acc. to Health CanadaHelmut 2019-02-05 17:52
  • for either the test or reference product? mittyri 2019-02-05 15:58
    • Discordant outliers Helmut 2019-02-05 17:42
  • Rules acc. to Health Canada Shuanghe 2019-02-06 11:48
    • Rules acc. to Health Canada ElMaestro 2019-02-06 12:20
      • ESD? mittyri 2019-02-06 14:04
        • ESD? ElMaestro 2019-02-06 18:12
  • Rules acc. to Health Canada zizou 2019-02-06 20:52
    • Great post! Helmut 2019-02-07 10:37