Bioequivalence and Bioavailability Forum • Subject exclusion

Subject exclusion [Outliers]

posted by Helmut – Vienna, Austria, 2018-10-03 01:27 (2392 d 11:01 ago) – Posting: # 19406
Views: 8,111

Salam Mohamed,

first of all: Please follow the Forum’s Policy about avoiding TOFU. THX.

❝ ;-) ok we will wait

In principle I agree with Ohlbe. But IMHO, “the subject didn’t swallow the drug” is not the only reason behind this statement in the GL. IIRC, this topic appeared for the first time in Rev.1 of the PKWP’s Q&A document in a section about omeprazole (updated in Rev.2, deleted in Rev.12). Esp. old – monolithic – gastric resistant PPI-formulations had problems with the coating. If you dive deeper into this issue you will face further questions, e.g.,

Do you start with the most obvious one and calculate the geometric mean of the others? Then you may find another one and repeat the procedure. Where will you end?
Note that the GL mentions “outlying subjects” (plural!). How can we classify AUCs as potential outliers without a test? Eye-ball PK?
Replicate designs. One low value and one “normal” value. Geometric mean or least squares mean?

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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 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 exclusionHelmut 2018-10-02 23:27
        
        Subject exclusion Mohamed Yehia 2018-10-02 23:51
        
        Subject exclusion Helmut 2018-10-03 23:47