Bioequivalence and Bioavailability Forum • "Removal" of an outlier: subject vs period

"Removal" of an outlier: subject vs period [Outliers]

posted by ElMaestro – Denmark, 2013-08-07 13:09 (4298 d 06:49 ago) – Posting: # 11230
Views: 11,642

Hi Mac,

❝ The question is, should this subject be removed completely from the study or just the period in question?

Where do you intend to submit?
What does your protocol say about outlier issues?
What do CRFs and raw data tell about the subject in question (or possibly: the subject in question compared to subjects you consider more normal or clustered around a mean of sorts)?

❝ (...) since we don't know what caused the "unusual" profile in the Test 2 profile, perhaps it's better to remove the subject altogether.

Or perhaps it is better not to remove any data at all in order to make sure that the true product performances are reflected in the CIs.

—
Pass or fail!
ElMaestro

Complete thread:

"Removal" of an outlier: subject vs period lechia 2013-08-06 23:23 [Outliers]
- "Removal" of an outlier: subject vs periodElMaestro 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 period lechia 2013-08-12 15:48