Bioequivalence and Bioavailability Forum • EU: parent

EU: parent [Power / Sample Size]

posted by Helmut – Vienna, Austria, 2013-02-23 13:07 (4868 d 00:58 ago) – Posting: # 10112
Views: 18,878

Dear Krishna,

❝ We are going prasugrel for EU submission. Kindly advise which metabolite to be evaluate (i.e R 95913 or R 138727) and show bio equivalence.

See my post above. R 95913 is inactive and metabolized to the active R 138727. If you have strong evidence that it is not possible with state of the art bioanalytics to measure the parent you may go with either of them. Personally I think EMA would prefer R 95913 since R 138727 is further “downstream” and differences (especially in C_max) will be less pronounced. If in doubt go for a scientific advice. Suggestion: Select a ‘difficult’ agency, e.g., the Spanish one.

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Helmut Schütz

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Complete thread:

Fasting vs Fed study sam 2012-11-26 09:49
- Prasugrel Helmut 2012-11-26 13:48
  - Prasugrel lukamar 2012-11-26 15:13
    - Prasugrel Helmut 2012-11-26 15:30
  - Prasugrel sam 2012-11-27 12:52
    - Prasugrel Dr_Dan 2012-11-27 14:19
    - Different ka and f Helmut 2012-11-27 14:56
      - Different ka and f? d_labes 2012-11-28 12:10
        
        Sorry. Forget it. Helmut 2012-11-28 15:42
        
        R code gem d_labes 2012-11-28 16:23
        
        R code gem Helmut 2012-11-28 16:54
      - Different ka and f sam 2012-11-28 12:38
        
        Different ka and f jag009 2012-11-29 16:30
    - Prasugrel jag009 2012-11-28 22:31
      - Prasugrel sam 2012-11-29 04:57
- Fasting vs Fed study drgunasakaran1 2012-11-27 14:17
  - For EU submission of Prasugrel venkata krishna 2013-02-23 06:40
    - EU: parentHelmut 2013-02-23 12:07