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 13:13 (4811 d 14:10 ago) – Posting: # 8426
Views: 13,785

Hi I think I concur with Helmut. To summarise;

Actual sampling times are the preferred input since deviations are then accounted for already. Then you are requesting partial AUC to nominal 72 h to have the EQUIVALENT time period for all subjects (as requested by the protocol).

That's how I've always analysed my data over the last 15+years. Slightly more tricky is when protocol requests 0-72 and some samples were not quantifiable at that timepoint, again if you have a value for Lz this will be extrapolated for you but for profiles with no Lz then WNL will do it's best to extrapolate, effectively using AUCall (or a fraction thereof) with all the inherent assumptions and approximations of that metric. On these occasions I would be tempted to consider reporting an AUC to last COMMON timepoint e.g. 48.

Again AUCinf(pred) would probably be a preferred comparison parameter, where available.

Simon

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Complete thread:

actual time AUC72 sciguy 2012-03-23 04:23 [NCA / SHAM]
- 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/reportSDavis 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