Bioequivalence and Bioavailability Forum • Canada: subject, not period

Canada: subject, not period [Outliers]

posted by lechia – C of U, 2013-08-12 17:48 (3909 d 00:31 ago) – Posting: # 11263
Views: 10,105

❝ Likely. The Canadian guidance talks only about removal of outlying subjects, not observations.

How about semi- and fully-replicate studies? Would you still suggest removal of the subject or just the period in question? In some sense, in scaled BE studies the replicate serves as a self-contained re-dose study (which the FDA accepts and EMEA does not).

Complete thread:

"Removal" of an outlier: subject vs period lechia 2013-08-06 23:23
- "Removal" of an outlier: subject vs period ElMaestro 2013-08-07 11:09
- Canada: subject, not period Helmut 2013-08-07 13:48
  - Proc GLM with missings d_labes 2013-08-07 14:46
    - Proc GLM with missings jag009 2013-08-07 15:03
    - Proc GLM with missings Helmut 2013-08-07 15:21
      - Proc GLM with missings ElMaestro 2013-08-07 15:39
        
        Proc GLM with missings ElMaestro 2013-08-07 16:22
        Proc GLM random d_labes 2013-08-07 16:46
      - Proc GLM with missings for 2x2 crossover d_labes 2013-08-07 16:34
  - Canada: subject, not period lechia 2013-08-07 15:46
    - Canada: subject, not period Helmut 2013-08-07 15:57
  - Canada: subject, not periodlechia 2013-08-12 15:48