An essential component of therapeutic drug/biomarker monitoring (TDM) is to combine patient data with prior knowledge for model‐based predictions of therapy outcomes. Current Bayesian forecasting tools typically rely only on the most probable model parameters (maximum a posteriori (MAP) estimate). This MAP‐based approach, however, does neither necessarily predict the most probable outcome nor does it quantify the risks of treatment inefficacy or toxicity. Bayesian data assimilation (DA) methods overcome these limitations by providing a comprehensive uncertainty quantification. We compare DA methods with MAP‐based approaches and show how probabilistic statements about key markers related to chemotherapy‐induced neutropenia can be leveraged for more informative decision support in individualized chemotherapy. Sequential Bayesian DA proved to be most computationally efficient for handling interoccasion variability and integrating TDM data. For new digital monitoring devices enabling more frequent data collection, these features will be of critical importance to improve patient care decisions in various therapeutic areas.
Drug approval is based on exposure, response, and variability of studied populations, typically excluding comorbidities/ medications and very ill patients, thus not representing realworld populations. This results in wide variability in therapeutic outcome for individual patients. Model-informed precision dosing (MIPD) can characterize/quantify this variability, support optimal dose selection, and enable individualized therapy. The aim of this perspective is to raise awareness for MIPD, identify challenges hindering its implementation in clinical practice, provide recommendations, and highlight opportunities.
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