Model-informed precision dosing: State of the art and future perspectives
I K Minichmayr1, E Dreesen2, M Centanni3
1Dept. of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.
Model-informed precision dosing (MIPD) personalizes medication by integrating mathematical models and patient data, advancing beyond traditional drug monitoring. Rigorous validation is key to its clinical application for better patient outcomes.
Area of Science:
- Pharmacology
- Personalized Medicine
- Computational Biology
Background:
- Model-informed precision dosing (MIPD) represents an advancement in personalized medicine, aiming to optimize drug regimens for individual patients.
- MIPD integrates mathematical modeling with patient-specific data, surpassing traditional therapeutic drug monitoring (TDM) by accounting for variability.
Purpose of the Study:
- To review novel methodologies in model selection and validation for MIPD.
- To explore the integration of machine learning, biosensors, and biomarkers in enhancing precision dosing.
- To discuss the clinical evidence and future directions for MIPD across various medical disciplines.
Main Methods:
- Review of current literature on model qualification, selection, and validation techniques for MIPD.
- Exploration of emerging technologies such as machine learning algorithms and biosensors for real-time drug monitoring.
- Analysis of pharmacokinetic/pharmacodynamic (PK/PD) principles and biomarker integration in precision dosing models.
Main Results:
- MIPD offers a sophisticated approach to tailoring drug doses by incorporating patient characteristics, drug measurements, and variability.
- Machine learning and biosensors show promise for improving the accuracy and real-time application of MIPD.
- Biomarker integration can further refine MIPD for predicting drug efficacy and toxicity.
Conclusions:
- Rigorous model qualification is essential for the safe and effective clinical implementation of MIPD.
- Evidence for TDM and MIPD exists across infection medicine, oncology, transplant medicine, and inflammatory bowel diseases.
- Further research, including randomized clinical trials, is needed to confirm MIPD's benefits in improving patient outcomes and advancing personalized medicine.
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