Bioequivalence and Bioavailability Forum • What a mess!

What a mess! [Regulatives / Guidelines]

posted by Shuanghe – Spain, 2015-09-25 18:32 (3462 d 06:28 ago) – Posting: # 15470
Views: 16,469

Dear Helmut,

❝ ... Given the reported CVs (@Shuanghe: Did you ever observe one <21.42%?) downscaling would be unlikely.

For AUC, yes. as low as 15% under fed, but for C_max, my lowest ISCV of R is about 24% under fed.

❝ I expect that the FDA’s guidance for yet another NOAC (apixaban) will be revised as well.

I'd expect it the same as those two.

—
All the best,
Shuanghe

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

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