Bioequivalence and Bioavailability Forum • Subject exclusion

Subject exclusion [Outliers]

posted by Ohlbe – France, 2018-10-03 00:35 (1706 d 02:10 ago) – Posting: # 19401
Views: 5,870

Dear Mohamed,

❝ It is stated that we have to remove outlier subjects for reference auc before making the geometric mean calculation. So I think that we have to include all the subjects including the one we want to check and check for the outlier first and in case there is no outlier we then calculate the geometric mean and check for 5 %.

I have a different understanding. Read the guideline again. The word "outlier" is not used anywhere in this section (and only once in the guideline, on a totally different topic). We're not looking for statistical outliers here, but for subjects who did not swallow the tablet. This 5% thing is just an arbitrary threshold that EMA is ready to accept to assume that the subject spat the tablet out.

—
Regards
Ohlbe

Complete thread:

Subject exclusion Mohamed Yehia 2018-10-02 21:25
- Subject exclusion Ohlbe 2018-10-02 21:30
  - Subject exclusion Mohamed Yehia 2018-10-02 21:38
    - Subject exclusion Ohlbe 2018-10-02 21:46
      - Subject exclusion Mohamed Yehia 2018-10-02 22:18
        
        Subject exclusionOhlbe 2018-10-02 22:35
        
        Subject exclusion Mohamed Yehia 2018-10-02 22:45
        
        Subject exclusion Ohlbe 2018-10-02 22:51
        
        Subject exclusion Mohamed Yehia 2018-10-02 22:55
        
        Subject exclusion Helmut 2018-10-02 23:27
        
        Subject exclusion Mohamed Yehia 2018-10-02 23:51
        
        Subject exclusion Helmut 2018-10-03 23:47