Bioequivalence and Bioavailability Forum • actual time AUC72

actual time AUC72 [NCA / SHAM]

posted by Dr_Dan – Germany, 2012-03-23 11:25 (4790 d 05:17 ago) – Posting: # 8321
Views: 13,507

Hi sciguy
According to CPMP/QWP/EWP/1401/98 Rev. 1
"4.1.5 Characteristics to be investigated
Pharmacokinetic parameters
Actual time of sampling should be used in the estimation of the pharmacokinetic parameters."
This holds true for all sampling points.
Kind regards
Dan

—
Kind regards and have a nice day
Dr_Dan

Complete thread:

actual time AUC72 sciguy 2012-03-23 04:23
- actual time AUC72Dr_Dan 2012-03-23 10:25
  - actual times and AUC72 d_labes 2012-03-27 09:22
    - actual times and AUC72 sciguy 2012-04-02 20:44
      - WNL/PHX: pAUC72 (=hidden intra-/extrapolation) Helmut 2012-04-03 00:33
        
        WNL/PHX: pAUC72 (=hidden intra-/extrapolation) sciguy 2012-04-03 15:50
        
        WNL/PHX: pAUC72 (=hidden intra-/extrapolation) Helmut 2012-04-03 15:56
        
        WNL/PHX: pAUC72 (=hidden intra-/extrapolation) sciguy 2012-04-03 16:10
        
        WNL/PHX: pAUC72 (=hidden intra-/extrapolation) Helmut 2012-04-03 16:16
        
        WNL/PHX: pAUC72 (=hidden intra-/extrapolation) sciguy 2012-04-05 16:27
        
        pAUC72 or pAUC72+x Helmut 2012-04-05 18:25
        actual time for INPUT, nominal for the summarisation/report SDavis 2012-04-17 11:13
        
        actual time for INPUT, nominal for the summarisation/report ElMaestro 2012-04-17 11:25
        
        actual time for INPUT, nominal for the summarisation/report SDavis 2012-04-17 13:35
        
        Fishy? ElMaestro 2012-04-17 13:42
        
        ... don't think so SDavis 2012-04-17 14:09
        
        ... don't think so ElMaestro 2012-04-17 17:20
        
        AUCall and that all - Fishy? d_labes 2012-04-17 15:45
        
        Genau Detlew! SDavis 2012-04-17 16:29