Bioequivalence and Bioavailability Forum • difficult to eliminate a subject

difficult to eliminate a subject [Outliers]

posted by ElMaestro – Denmark, 2011-03-10 13:20 (4471 d 06:38 ago) – Posting: # 6736
Views: 7,152

Hi SK,

❝ On review of p'cokinetic data it was observed that one of subject is showing highest T/R ratio for Cmax and AUC. So we just recalculate 90% CI by excluding that subject and those results were within acceptance limit. No specific outlier test is applied here.

If you have just pulled out the subject with the highest T/R without any further qualification then that won't be acceptable. If you have confirmed technical issues with the samples then you may be able to take out the subject, same thing if the subject vomited etc.

—
Pass or fail!
ElMaestro

Complete thread:

Handling of outlier (EU) swapnil.kuche 2011-03-09 07:19
- EU: no re-dosing Helmut 2011-03-09 12:40
  - EU: no re-dosing swapnil.kuche 2011-03-10 06:39
    - difficult to eliminate a subjectElMaestro 2011-03-10 12:20
      - difficult to eliminate a subject Helmut 2011-03-10 12:39
    - EU: ways out? Helmut 2011-03-10 12:29
      - EU: ways out? swapnil.kuche 2011-03-11 05:26