Bioequivalence and Bioavailability Forum • WNL/PHX: pAUC72 (=hidden intra-/extrapolation)

WNL/PHX: pAUC72 (=hidden intra-/extrapolation) [NCA / SHAM]

posted by sciguy – Canada, 2012-04-05 18:27 (4777 d 04:26 ago) – Posting: # 8387
Views: 13,382

Dear Helmut!

❝ Now we are going in circles. :-D Was 72.6 h the “latest” sampling in any of the subjects? If yes and you set pAUC in PHX/WNL to 72.6 h all AUCs of subjects with t_last<72.6 will be extrapolated. I would rather set the limit for pAUC to 72 h.

Yes, 72.6 was the latest sampling time observed. For a BE study, I understand the rationale of setting the pAUC limit to 72hr. But....for an exploratory PK study (where there is no equivalence assessment), should we still set this limit (ie: is there any reason to just use each subject's actual time at 72hr?) My guess is to just stick with the 72 hr limit..

Thanks!
sciguy

Complete thread:

actual time AUC72 sciguy 2012-03-23 04:23
- actual time AUC72 Dr_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