Bioequivalence and Bioavailability Forum

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 C_max”.

❝ … bioanalytical method?

No.