Bioequivalence and Bioavailability Forum • The FDA’s fourth BE approach!

The FDA’s fourth BE approach! [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2015-09-22 15:25 (3467 d 11:15 ago) – Posting: # 15443
Views: 17,294

Hi nobody,

❝ Please elucidate the scientific background for the "upper limit of the 90% confidence interval for the test-to-reference ratio of the within-subject variability should be ≤ 2.5" of FDA dabigatran BE guidance

As if pulling a rabbit out of the hat. László Endrényi regularly goes ballistic on this issue. He showed already twenty years ago (in the context of IBE) that this limit is arbitrary and the “method” flawed.

—
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Helmut Schütz

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Science Quotes

Complete thread:

New D. Guidance – Dabigatran jag009 2015-09-21 23:19 [Regulatives / Guidelines]
- New D. Guidance – Dabigatran nobody 2015-09-22 11:04
  - The FDA’s fourth BE approach! Helmut 2015-09-22 11:43
    - The FDA’s fourth BE approach! nobody 2015-09-22 13:06
      - The FDA’s fourth BE approach!Helmut 2015-09-22 13:25
        
        The FDA’s fourth BE approach! Yada Yada Yada jag009 2015-09-23 20:29
        
        Yucky… Helmut 2015-09-23 22:06
    - The FDA’s fourth BE approach! d_labes 2015-09-22 14:08
      - New PowerTOST function(s) Helmut 2015-09-22 14:27
        
        New PowerTOST function(s) d_labes 2015-09-22 14:59
        
        Pradaxa = HVDP (dabigatran = HVD?) Helmut 2015-09-22 15:16
        
        Pradaxa = HVDP (dabigatran = HVD?) Shuanghe 2015-09-22 16:53
        
        HVNTID's d_labes 2015-09-23 08:34
        
        HVNTID's Shuanghe 2015-09-25 16:14
        
        Highly variable NTID d_labes 2015-09-23 08:23
        
        What a mess! Helmut 2015-09-23 13:20
        
        Messy numbers - PowerTOST V1.3-01 preview d_labes 2015-09-24 09:18
        What a mess! Shuanghe 2015-09-25 16:32
      - OT: power.NTIDFDA() Helmut 2015-09-23 00:10
        
        OT: power.NTIDFDA() d_labes 2015-09-23 09:37