Bioequivalence and Bioavailability Forum • Rules acc. to Health Canada

Rules acc. to Health Canada [Outliers]

posted by Ohlbe – France, 2019-02-05 16:54 (2337 d 08:16 ago) – Posting: # 19870
Views: 9,923

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

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 CanadaOhlbe 2019-02-05 15:54
  - Rules acc. to Health Canada Helmut 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