Bioequivalence and Bioavailability Forum • actual time for INPUT, nominal for the summarisation/report

actual time for INPUT, nominal for the summarisation/report [NCA / SHAM]

posted by SDavis – UK, 2012-04-17 15:35 (4765 d 02:09 ago) – Posting: # 8430
Views: 14,387

Hi - I just warning people of the simple assumptions that AUCall makes as illustrated in this image http://www.pharmpk.com/pk/AUCinf.jpg
[image]

Basically draws a straight line to the next SAMPLED point from Tlast.

SO if we look at the 3 profiles below, Subject 1 and 2 since they are either sampled to, or beyond 24 h, but subject 3 is not quantifiable after 12h. The redline I drew on here (12-24h) shoes how AUCall would be described and you can see that it could be quite different to an AUC24 that have been calculated by extrapolating. [image]

Note in the NCA results AUClast=AUCall for Subjects 1 & 2 where last sampled point was quantifiable. [image]

Simon.

—
Simon
Senior Scientific Trainer, Certara™
[link=https://www.youtube.com/watch?v=xX-yCO5Rzag[/link]
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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/reportSDavis 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