Bioequivalence and Bioavailability Forum • FDA and outliers

FDA and outliers [Study Assessment]

posted by mittyri - Russia, 2018-12-11 16:38 - Posting: # 19681
Views: 574

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 outliers - mittyri, 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

Bioequivalence and Bioavailability Forum 12:54 CET

FDA and outliers [Study As­sess­ment]

Complete thread:

FDA and outliers [Study Assessment]