Bioequivalence and Bioavailability Forum • actual times and AUC72

actual times and AUC72 [NCA / SHAM]

posted by sciguy – Canada, 2012-04-02 22:44 (4779 d 18:34 ago) – Posting: # 8373
Views: 13,310

Hello Dr.Dan and d_labes!

❝ Do you refer to how to act in case of some time deviations at 72h?

❝ Use AUC up to the actual time (f.i. AUC0-73.5h) as your measure for AUC0-72h?

Yes, this is what I meant. I couldn't remember if AUC0-72 really means AUC0-72 or AUC0-72.xx (whatever your actual time at 72h is)

❝ My habit (and I know others here in the forum :cool: ) was up to now to do an inter-/extrapolation to the scheduled time 72h and then calculate AUC0-72h with that inter-/extrapolated concentration.

I see...thanks for the link. I set up partial areas in WNL to define the actual time rather than inter/extrapolate at 72. Is it clear from a regulatory perspective (ie: FDA/EMA) that inter/extrapolation is required? Obviously, if time deviations are large, it makes sense to do this since there would be a major difference between AUC0-72 vs say, AUC0-76.3.

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 AUC72sciguy 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