Bioequivalence and Bioavailability Forum • BE for HVD (EMA)

BE for HVD (EMA) [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2014-02-15 16:10 (4513 d 09:05 ago) – Posting: # 12433
Views: 6,110

Hi PK_Lover,

I agree with Detlew about the “political reasons” (for the history see this post). From a scientific point of view limiting ABEL to C_max doesn’t make sense – think about bisphosphonates… I think that the cap at 50% CV_WR was introduced to keep consistency with the many studies which were performed in the past. EMA didn’t want to aim higher.

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Helmut Schütz

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Complete thread:

BE for HVD (EMA) nasir 2014-02-14 06:38
- BE for HVD (EMA): no 2x2 crossover d_labes 2014-02-14 09:27
  - CV >30% in the study Helmut 2014-02-14 14:35
- BE for HVD (EMA) kvgreddy06 2014-02-14 16:18
  - BE for HVD (EMA) PK_Lover 2014-02-14 18:37
    - EMA: No widening of acceptance limits for AUC d_labes 2014-02-14 20:03
    - BE for HVD (EMA)Helmut 2014-02-15 15:10
      - BE for HVD (EMA) nasir 2014-02-18 07:24
        
        Single point metric… Helmut 2014-02-18 13:03
        
        Single point metric… nasir 2014-02-18 19:57
        
        Single point metric… Helmut 2014-02-18 20:38
        
        Single point metric… nasir 2014-02-19 07:09
        
        MR GL – when? Helmut 2014-02-19 13:10