AUC passes, Cmax fails: biopharmaceutical difference [PK / PD]

posted by Helmut Homepage – Vienna, Austria, 2021-03-23 11:03 (131 d 20:38 ago) – Posting: # 22292
Views: 600

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.

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