Bioequivalence and Bioavailability Forum

FDA and outliers [Study Assessment]

posted by mittyri – Russia, 2018-12-11 16:38 (859 d 08:06 ago) – Posting: # 19681
Views: 5,590

Dear Mann,

I don't think the position of FDA is different.
Please see this old post.

Do you have any experience of BEQ analysis for submission in FDA/EMA jurisdiction?
Where is the idea of outliers coming from?
Do the results without any outliers analysis also show not-BE?

—
Kind regards,
Mittyri

Complete thread:

BE assessment regarding first time point Cmax Mann 2018-12-09 10:14 [Study Assessment]
- BE assessment regarding first time point Cmax Ohlbe 2018-12-09 23:46
  - BE assessment regarding first time point Cmax Mann 2018-12-10 00:28
    - BE assessment regarding first time point Cmax Ohlbe 2018-12-11 00:05
    - FDA and outliersmittyri 2018-12-11 16:38
    - BE assessment regarding first time point Cmax Erkin 2018-12-28 08:29
      - BE assessment regarding first time point Cmax ElMaestro 2018-12-28 14:32
        
        BE assessment regarding first time point Cmax Erkin 2018-12-28 20:57
        
        regulatory reasons to consider the study inadequate Astea 2019-03-02 18:02
        
        Good question, next question Helmut 2019-03-03 19:42
        
        first point Cmax: trouble waiting to happen? Astea 2019-03-03 21:42

FDA and outliers [Study As­sess­ment]

Complete thread:

FDA and outliers [Study Assessment]