Bioequivalence and Bioavailability Forum

Conc at dosing interval [General Statistics]

posted by jag009 – NJ, 2013-11-26 18:31 (3801 d 21:42 ago) – Posting: # 11977
Views: 13,285

Hi Helmut,

❝ Yes, that’s a nice one! Currently for EMA BE of MR products has to be demonstrated both after SD and in steady state. Paixão et al.¹ showed that for drugs with linear PK C_τ is predictive of steady state.² We will see whether the mighty oracle will accept this approach and drop the requirement of MD studies in the final guideline.

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

John

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 intervaljag009 2013-11-26 17:31
        
        Conc at dosing interval Helmut 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

Conc at dosing interval [General Sta­tis­tics]

Complete thread:

Conc at dosing interval [General Statistics]