Bioequivalence and Bioavailability Forum • pAUC72 or pAUC72+x

pAUC72 or pAUC72+x [NCA / SHAM]

posted by Helmut – Vienna, Austria, 2012-04-05 20:25 (4824 d 08:39 ago) – Posting: # 8391
Views: 13,812

Dear sciguy!

❝ 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..

In a PK study maybe you are interested in modeling as well? Just use the actual time points. Even if you stick with NCA, more emphasis in this type of study lies on AUC_∞ anyway (prediction of steady state based on superposition etc.). For the reasoning of the truncation time point of 72 hours see my final remark in this post. In real life we rarely see negative time deviations (i.e., sample taken too early); might only be relevant if the last sample is missing. Generally the sample is taken either at the nominal time point or is delayed. If you have taken the latest sample in the study at 72.6 hours it would mean that you have to extrapolate all the others – a procedure I (!) would not prefer.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

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+xHelmut 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