What ’bout science? [NCA / SHAM]

posted by Helmut Homepage – Vienna, Austria, 2016-02-11 17:43  – Posting: # 15976
Views: 3,612

Hi Compliance,

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

[image]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.

Helmut Schütz

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