Bioequivalence and Bioavailability Forum • Experiences with EU submissions

Experiences with EU submissions [Bioanalytics]

posted by Helmut – Vienna, Austria, 2013-01-10 15:03 (4914 d 05:00 ago) – Posting: # 9816
Views: 8,888

Hi John,

no experiences with the FDA so far. In the few similar cases for European submissions we had data demonstrating that we were pushing the analytical method to the state of the art’s limits. We also had pilot studies showing that the methods were not capable of delivering reliable PK-metrics. In all cases we went to scientific advisory meetings. The metabolite was accepted – in one case (December 2012) even a secondary one!

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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Complete thread:

FDA definition of non-accurately and reliably jag009 2013-01-09 22:20
- Experiences with EU submissionsHelmut 2013-01-10 14:03
  - Experiences with EU submissions jag009 2013-01-10 16:36
    - Experiences with EU submissions Helmut 2013-01-10 16:56
      - Experiences with EU submissions jag009 2013-01-10 20:07
        
        LLOQ “low enough”? Helmut 2013-01-10 20:46
        
        LLOQ “low enough”? jag009 2013-01-11 15:20
        
        LLOQ “low enough”? Ohlbe 2013-01-11 19:16
        
        LLOQ “low enough”? jag009 2013-01-11 20:14