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RegisterK elimination determination [NCA / SHAM]
Background: One of my study of enalapril maleate passed cleanely in Cmax and AUC(t) but failed in AUC(inf)
AUC(inf) is given an equal (33%) importance in BE criteria. Now AUC(inf) depends on ke value. While preparing the protocol generally time points at elimination phase are kept at distance of around 10-12 hrs (eg of drug with half life of say 20 hrs will have time points of 24.00, 36.00, 48.00, 96.00) and these concentration values give a chaotic ke. I want to know the approach to get the true ke for getting my studies spared from AUC(inf) failure (time points selection base).
HP
Edit: Category changed. [Helmut]
AUC(inf) is given an equal (33%) importance in BE criteria. Now AUC(inf) depends on ke value. While preparing the protocol generally time points at elimination phase are kept at distance of around 10-12 hrs (eg of drug with half life of say 20 hrs will have time points of 24.00, 36.00, 48.00, 96.00) and these concentration values give a chaotic ke. I want to know the approach to get the true ke for getting my studies spared from AUC(inf) failure (time points selection base).
HP
Edit: Category changed. [Helmut]
Complete thread:
- K elimination determinationhiren 2010-10-02 15:49
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- K elimination determination yjlee168 2010-10-04 23:45
- K elimination determination Helmut 2010-10-05 02:24
- K elimination determination hiren 2010-10-05 16:42
- K elimination determination yjlee168 2010-10-04 23:45
Ing. Helmut Schütz