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RegisterWhy is just Cmax out of specification? [PK / PD]
Hi Everyone,
I want to know that why while auc with in spect Cmax out of it? its means that test has higher dissolution rate everytime, or can cause another thing such as CRO, design of study, bioanalytical method?
I want to know that why while auc with in spect Cmax out of it? its means that test has higher dissolution rate everytime, or can cause another thing such as CRO, design of study, bioanalytical method?
Complete thread:
- Why is just Cmax out of specification?akif 2021-03-22 20:36 [PK / PD]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- AUC passes, Cmax fails: biopharmaceutical difference Helmut 2021-03-23 11:03
- AUC passes, Cmax fails: biopharmaceutical difference akif 2021-03-24 16:59
- AUC passes, Cmax fails: biopharmaceutical difference Helmut 2021-03-23 11:03
Ing. Helmut Schütz