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RegisterAUC∞ = lousy metric [NCA / SHAM]
Hi Helmut,
True because AUCi is based on extrapolation of the terminal phase Kel which can cause all kind of issues when the concentrations in the elimination phase become erratic due to pk complexity and other factors.
I was just wondering if you all experienced (okay, FDA only studies) such scenarios, what kind of approach you used and what the outcome was (meaning did the agency agree to only Cmax and AUCt).
Like I said a while back a clinic I used previously would consider kel as "cannot-be-determined" if the last 2 (or 1) timepoints showed a +ve increase in concentration relative to the timepoints before.
Thanks
John
True because AUCi is based on extrapolation of the terminal phase Kel which can cause all kind of issues when the concentrations in the elimination phase become erratic due to pk complexity and other factors.
I was just wondering if you all experienced (okay, FDA only studies) such scenarios, what kind of approach you used and what the outcome was (meaning did the agency agree to only Cmax and AUCt).
Like I said a while back a clinic I used previously would consider kel as "cannot-be-determined" if the last 2 (or 1) timepoints showed a +ve increase in concentration relative to the timepoints before.
Thanks
John
Complete thread:
- Failing BE study due to AUCinf jag009 2013-06-19 17:44
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- AUC∞ = lousy metric Helmut 2013-06-19 18:15
- AUC∞ = lousy metricjag009 2013-06-19 19:35
- AUC∞ = lousy metric jag009 2013-06-19 21:20
- AUC∞ = lousy metric Helmut 2013-06-20 17:29
- AUC∞ = lousy metric jag009 2013-06-20 20:32
- AUC∞ = lousy metric Helmut 2013-06-20 17:29
- Failing BE study due to AUCinf ElMaestro 2013-06-19 18:48
- Failing BE study due to AUCinf jag009 2013-06-19 19:41
- AUC∞ = lousy metric Helmut 2013-06-19 18:15
Ing. Helmut Schütz