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

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

posted by jag009 – NJ, 2015-09-23 22:29 (3575 d 19:32 ago) – Posting: # 15461
Views: 17,512

Hi Helmut,

❝ 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.

I was in one local BA/BE meeting last week in NJ. One of the ex-FDA presenter (consultant) made a short "blasting" speech on the Sub*formulation interaction test on Concerta... I wonder when my old prof Laszlo will start his own campaign....

John

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 Yadajag009 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