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Registeractual times and AUC72 [NCA / SHAM]
Dear Dan, dear sciguy!
The question and the answer are little bit ambiguous to me.
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?
My habit (and I know others here in the forum
) was up to now to do an inter-/extrapolation to the scheduled time 72h and then calculate AUC0-72h with that inter-/extrapolated concentration.
This also is in accordance with Dan's excerpt of the EMA BE guidance, I think.
Of course this will usually not make a great difference if the time devs are small and the concentrations at 72h also.
The 'missing 72h' is inherently quite another cup of tea (see f.i. here).
But for other 'truncated' AUC also 'small' time deviations may be of great influence. Imagine early exposure partial AUC's, f.i. AUC0-30min.
The question and the answer are little bit ambiguous to me.
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?
My habit (and I know others here in the forum
) was up to now to do an inter-/extrapolation to the scheduled time 72h and then calculate AUC0-72h with that inter-/extrapolated concentration.This also is in accordance with Dan's excerpt of the EMA BE guidance, I think.
Of course this will usually not make a great difference if the time devs are small and the concentrations at 72h also.
The 'missing 72h' is inherently quite another cup of tea (see f.i. here).
But for other 'truncated' AUC also 'small' time deviations may be of great influence. Imagine early exposure partial AUC's, f.i. AUC0-30min.
—
Regards,
Detlew
Regards,
Detlew
Complete thread:
- actual time AUC72 sciguy 2012-03-23 04:23
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- actual time AUC72 Dr_Dan 2012-03-23 10:25
- actual times and AUC72d_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/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
- ... don't think so SDavis 2012-04-17 14:09
- Fishy? ElMaestro 2012-04-17 13:42
- actual time for INPUT, nominal for the summarisation/report SDavis 2012-04-17 13:35
- actual time for INPUT, nominal for the summarisation/report ElMaestro 2012-04-17 11:25
- WNL/PHX: pAUC72 (=hidden intra-/extrapolation) sciguy 2012-04-05 16:27
- WNL/PHX: pAUC72 (=hidden intra-/extrapolation) Helmut 2012-04-03 16:16
- WNL/PHX: pAUC72 (=hidden intra-/extrapolation) sciguy 2012-04-03 16:10
- WNL/PHX: pAUC72 (=hidden intra-/extrapolation) Helmut 2012-04-03 15:56
- WNL/PHX: pAUC72 (=hidden intra-/extrapolation) sciguy 2012-04-03 15:50
- WNL/PHX: pAUC72 (=hidden intra-/extrapolation) Helmut 2012-04-03 00:33
- actual times and AUC72 sciguy 2012-04-02 20:44
- actual times and AUC72d_labes 2012-03-27 09:22
- actual time AUC72 Dr_Dan 2012-03-23 10:25
Ing. Helmut Schütz