AUC passes, Cmax fails: biopharmaceutical difference [PK / PD]
Merhaba akif,
» I want to know that why while auc with in spect Cmax out of it? its means that test has higher dissolution rate everytime, …
Only if your drug is in BCS class I or – under certain conditions – in class III, dissolution plays a major rule. If in class II/IV, dissolution is not predictive. There are a manifold of reasons with the absorption rate differs between products. Even if excipients and their amount are identical, differences in the manufacturing process may explain the different absorption.
» … or can cause another thing such as CRO, …
No.
» … design of study, …
Only if you have problems with a “first point Cmax”.
» … bioanalytical method?
No.
» I want to know that why while auc with in spect Cmax out of it? its means that test has higher dissolution rate everytime, …
Only if your drug is in BCS class I or – under certain conditions – in class III, dissolution plays a major rule. If in class II/IV, dissolution is not predictive. There are a manifold of reasons with the absorption rate differs between products. Even if excipients and their amount are identical, differences in the manufacturing process may explain the different absorption.
» … or can cause another thing such as CRO, …
No.
» … design of study, …
Only if you have problems with a “first point Cmax”.
» … bioanalytical method?
No.
—
Dif-tor heh smusma 🖖![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
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Dif-tor heh smusma 🖖
![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Why is just Cmax out of specification? akif 2021-03-22 20:36 [PK / PD]
- AUC passes, Cmax fails: biopharmaceutical differenceHelmut 2021-03-23 11:03
- AUC passes, Cmax fails: biopharmaceutical difference akif 2021-03-24 16:59
- AUC passes, Cmax fails: biopharmaceutical differenceHelmut 2021-03-23 11:03