Bioequivalence and Bioavailability Forum • Handling of outlier (EU)

Handling of outlier (EU) [Outliers]

posted by swapnil.kuche – 2011-03-09 08:19 (5179 d 08:48 ago) – Posting: # 6730
Views: 10,047

Dear All,

Due to one outlier subject one of our pivotal study is failing. In such case can we perform redosing for approximately 20% (of original sample size) subjects to confirm the results and to support our application (MA). Nowadays this approach is used for USFDA but can you please update me regarding EU view on the same.

Thanks in advance
Swapnil

Complete thread:

Handling of outlier (EU)swapnil.kuche 2011-03-09 07:19 [Outliers]
- 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 subject ElMaestro 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