Abstract

In Therapeutic Drug Monitoring (TDM), does and intervals of administration are adjusted according to the individual patient based on plasma concentrations predicted from one or two measurements of the patient. Such monitoring has been applied to many kinds of drugs and is necessary in the study of Kampo formulations too. In this kind of monitoring, the selection of measurement points is quite important in order to achieve accurate predictions. The purpose of this paper is to propose a Monte Carlo approach to the selection of the optimum measurement point to predict plasma concentrations of a drug. The proposed approach is applied to the data obtained in a clinical phase-one study of a Kampo formulation. The necessity of Therapeutic Drug Monitoring for Kampo formulations is also discussed.

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