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Abstract

Therapeutic Drug Monitoring (TDM) is a key concept in precision medicine. The goal of TDM is to avoid therapeutic failure or toxic effects of a drug due to insufficient or excessive circulating concentration exposure related to between-patient variability in the drug's disposition. We present TUCUXI - an intelligent system for TDM. By making use of embedded mathematical models, the software allows to compute maximum likelihood individual predictions of drug concentrations from population pharmacokinetic data, based on patient's parameters and previously observed concentrations. TUCUXI was developed to be used in medical practice, to assist clinicians in taking dosage adjustment decisions for optimizing drug concentration levels. This software is currently being tested in a University Hospital. In this paper we focus on the process of software integration in clinical workflow. The modular architecture of the software allows us to plug in a module enabling data aggregation for research purposes. This is an important feature in order to develop new mathematical models for drugs, and thus to improve TDM. Finally we discuss ethical issues related to the use of an automated decision support system in clinical practice, in particular if it allows data aggregation for research purposes.

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