Bioequivalence and Bioavailability Forum • failed BE study

failed BE study [Regulatives / Guidelines]

posted by Dr_Dan – Germany, 2010-06-03 11:21 (5871 d 00:22 ago) – Posting: # 5422
Views: 7,625

Dear ElMaestro
Thanks for your reply. I agree that this issue will be assessed differently across EU countriesit and surely it will be a great difference whether or not the product is submitted in a dcp or nationally. Actually I have the following problem: 3 studies, US fasted and fed bioequivalent, EU failed (upper CI for Cmax 125.1%). US and EU reference have a different formulation, test was the same. Failed EU study: Point estimator for Cmax 117%, for AUC 87% => test and reference different formulations with different PK. Honestly I see no chance. Do you agree that a second BE study would not convince the assessor even if bioequivalence is shown?
Kind regrads
Dan

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Kind regards and have a nice day
Dr_Dan

Complete thread:

failed BE study Dr_Dan 2010-06-02 14:57
- failed BE study ElMaestro 2010-06-02 22:36
  - failed BE studyDr_Dan 2010-06-03 09:21
    - there's hope ElMaestro 2010-06-04 01:48
      - disagree Dr_Dan 2010-06-04 13:13
        
        disagree ElMaestro 2010-06-04 15:26
        Disagree and agree Ohlbe 2010-06-05 00:39
        
        Disagree and agree #2 Helmut 2010-06-05 23:31
        
        Disagree and agree #2 ElMaestro 2010-06-06 20:31
        
        Disagree and agree #2 Helmut 2010-06-06 21:43
        
        Disagree and agree #2 ElMaestro 2010-06-06 22:44
- failed BE study statistician 2010-06-05 08:43
  - Tales of mystery and imagination Jaime_R 2010-06-05 12:07
    - SCNR Helmut 2010-06-05 19:27
    - changed assessment Dr_Dan 2010-06-08 11:32
      - changed assessment Jaime_R 2010-06-08 12:05
      - changed assessment ElMaestro 2010-06-08 20:42