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RegisterAUC passes, Cmax fails: biopharmaceutical difference [PK / PD]
posted by Helmut 
– Vienna, Austria, 2021-03-23 12:03 (686 d 04:17 ago) – Posting: # 22292
Views: 1,065
Merhaba akif,
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.
No.
Only if you have problems with a “first point Cmax”.
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.
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
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]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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
Ing. Helmut Schütz