- Model-Informed Precision Dosing (MIPD) is an advanced clinical approach that uses mathematical and computational models to individualize drug dosing based on both population-level pharmacokinetic/pharmacodynamic (PK/PD) knowledge and patient-specific characteristics. Unlike traditional dosing strategies, which often rely on fixed dosing regimens or broad guidelines, MIPD integrates a variety of data sources—such as patient weight, age, renal function, liver function, genetic markers, and real-time drug levels—into predictive models that can optimize therapeutic outcomes while minimizing adverse effects.
- At the heart of MIPD is the use of population PK/PD models, which describe how drugs behave in the body across a group of individuals. These models serve as a foundation and are refined through the use of Bayesian forecasting. In this process, prior knowledge from population data is updated with individual patient data to make personalized predictions. For example, if a patient’s drug concentration is measured during therapy, this information can be used to adjust the model’s parameters and recommend a more accurate, individualized dose.
- MIPD is especially valuable in clinical areas where there is a narrow therapeutic index or high interindividual variability in drug response. Common applications include dosing of antibiotics like vancomycin and aminoglycosides, antifungals such as voriconazole, immunosuppressants like tacrolimus, and certain chemotherapy agents including methotrexate and busulfan. These drugs require precise dosing to achieve efficacy without causing toxicity, making them ideal candidates for model-based individualization.
- Clinical implementation of MIPD often involves therapeutic drug monitoring (TDM), but with a significant enhancement: instead of using fixed concentration thresholds, MIPD tools simulate and forecast the most effective dose based on dynamic modeling. There are several software platforms that support MIPD, such as NONMEM and Monolix for modeling, and clinical decision support tools like InsightRx, DoseMeRx, and PrecisePK, which can integrate with electronic health records (EHRs) to provide real-time dose recommendations at the point of care.
- Looking ahead, MIPD is poised to become a cornerstone of precision medicine. Integration with pharmacogenomics—such as accounting for cytochrome P450 polymorphisms—will allow for even more tailored therapy. Additionally, machine learning and artificial intelligence are being explored to enhance predictive accuracy and automate parts of the decision-making process. In the future, clinicians may be able to access real-time, bedside dosing guidance through mobile applications or cloud-based systems, further increasing the reach and efficiency of MIPD in diverse clinical settings.
