Bioequivalence and Bioavailability Forum

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

posted by SDavis  – UK, 2012-04-17 15:35 (4811 d 14:44 ago) – Posting: # 8430
Views: 14,847

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


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.

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

Simon.

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/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