Bioequivalence and Bioavailability Forum

Hi Compliance,

» Please teach me how to decide/ fix partial AUC regimen.

Impossible without a crystal ball. You should know the PK/PD of the API and the properties of the formulation.

» Europe guidance for modified release formulation ask for the partial AUC but i don't have knowledge how to select regimen for partial AUC.

The GL states:

An early _partialAUC_{(0 – cut-off t)} and a terminal _partialAUC_{(cut-off t - tlast)}, separated by a predefined cut-off time point, e.g. the half of the dosage interval are recommended, unless otherwise scientifically justified.

In other words, if you have no clue you could always use τ/2. For some formulations (e.g., biphasic release) such a cut-off is meaningless and IMHO, for the others of doubtful value. I cannot imagine a situation where I would ever use it myself. That’s why the second option was added in the final version. Up to you.