Bioequivalence and Bioavailability Forum • Subject exclusion

Subject exclusion [Outliers]

posted by Mohamed Yehia – Egypt, 2018-10-03 00:18 (1706 d 01:20 ago) – Posting: # 19400
Views: 5,888

Dear Ohlbe,

❝ The guideline does not ask for any statistical outlier test to be performed. If you have a subject with very low concentrations, calculate the geometric mean of the AUC of the reference without that subject. If the AUC of the subject for the reference product is lower than 5 % of that mean you have a possibility to exclude him. That's all.

It is stated that we have to remove outlier subjects for reference auc before making th geometric mean calculation. So I think that we have to include all the subjects inckuding 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 %.

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [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 exclusionMohamed Yehia 2018-10-02 22:18
        
        Subject exclusion Ohlbe 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