Bioequivalence and Bioavailability Forum • Conc at dosing interval

Conc at dosing interval [General Statistics]

posted by Helmut – Vienna, Austria, 2013-11-27 14:10 (4221 d 19:12 ago) – Posting: # 11980
Views: 14,850

Hi John!

❝ I never agree to the cancelling of steady state study by FDA because there are some cases where SD study is not entirely sensitive...

Do you have any examples (except drugs with nonlinear PK) where SD passed and MD failed? See also this post.

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Complete thread:

Simulation of data to predict Steady state cakhatri 2013-11-24 10:13 [General Statistics]
- Nonparametric superposition Helmut 2013-11-24 14:30
  - Nonparametric superposition jag009 2013-11-24 23:13
    - Nonlinear nightmare Helmut 2013-11-25 02:56
      - Nonlinear nightmare jag009 2013-11-25 17:43
        
        Nonlinear nightmare Helmut 2013-11-26 14:32
        
        Nonlinear nightmare jag009 2013-11-26 16:00
        
        OT: Vienna Helmut 2013-11-26 16:27
        
        OT: Vienna jag009 2013-11-26 17:29
        
        OT: Vienna Helmut 2013-11-27 13:04
  - Conc at dosing interval jag009 2013-11-25 17:48
    - Conc at dosing interval Helmut 2013-11-26 15:01
      - Conc at dosing interval jag009 2013-11-26 17:31
        
        Conc at dosing intervalHelmut 2013-11-27 13:10
        
        Conc at dosing interval jag009 2013-11-27 20:00
        Passing SD and Failing MD luvblooms 2013-11-28 09:19
        
        Passing SD and Failing MD Helmut 2013-11-29 17:29
        
        Passing SD and Failing MD luvblooms 2013-11-29 18:57
        
        Cτ predictive of Cmin Helmut 2013-11-30 17:25

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