About this Research Topic
The goal of this Research Topic is to present the latest advances in the field of model-informed precision dosing with the ultimate aim to increase visibility and facilitate further implementation in clinical practice.
Model-informed precision dosing is a next generation dosing paradigm in which mathematical models for drugs and diseases, in combination with individually measured patient characteristics (e.g. drug concentration, genotype, organ function) and disease characteristics (e.g. pathogen susceptibility), are used to calculate the optimal dose. As computer technology is becoming more and more available at the bedside, we stand at the brink of model-informed precision dosing to be implemented as standard of care.
In the current era of precision medicine, more and more drugs are being developed for disease-specific targets. However, a lot of drugs are still not used optimally. For example, drug dosing regimens are often developed for prescriber convenience rather than for a specific patient, leaving the individual patient deprived from its optimal dose. Furthermore, special patient populations, like obese patients, neonates, pregnant women and patients with drug-drug interactions are difficult to recruit in clinical trials. Consequently, there is high uncertainty about the best dose in these populations.
These hurdles can be overcome by model-informed precision dosing, which allows integration of all available knowledge on a drug in a mathematical model and use this to inform individual treatment. Model-informed precision dosing may become standard of care by approval of companion dosing tools. For example, the FDA approved its first companion tool for octocog alfa, a drug for treatment and prevention of bleeding in patients with hemophilia A. Furthermore, novel dosing algorithms may be developed for existing drugs that are still dosed as when they initially came on the market decades ago.
The use model-informed precision dosing may lead to more efficacy and less side effects, for example, reduced antimicrobial drug resistance or decreased incidence of febrile neutropenia for classic cytotoxic anticancer drugs. Furthermore, model-informed precision dosing may be used to reduce ‘financial toxicity’ of novel expensive drugs, for example by means individualized dose tapering.
For this Research Topic, we welcome Original Research, Reviews and Opinion letters on model-informed precision dosing. Both technical and clinical implementation research fall within the scope.
Model-informed precision dosing is a next generation dosing paradigm in which mathematical models for drugs and diseases, in combination with individually measured patient characteristics (e.g. drug concentration, genotype, organ function) and disease characteristics (e.g. pathogen susceptibility), are used to calculate the optimal dose. As computer technology is becoming more and more available at the bedside, we stand at the brink of model-informed precision dosing to be implemented as standard of care.
In the current era of precision medicine, more and more drugs are being developed for disease-specific targets. However, a lot of drugs are still not used optimally. For example, drug dosing regimens are often developed for prescriber convenience rather than for a specific patient, leaving the individual patient deprived from its optimal dose. Furthermore, special patient populations, like obese patients, neonates, pregnant women and patients with drug-drug interactions are difficult to recruit in clinical trials. Consequently, there is high uncertainty about the best dose in these populations.
These hurdles can be overcome by model-informed precision dosing, which allows integration of all available knowledge on a drug in a mathematical model and use this to inform individual treatment. Model-informed precision dosing may become standard of care by approval of companion dosing tools. For example, the FDA approved its first companion tool for octocog alfa, a drug for treatment and prevention of bleeding in patients with hemophilia A. Furthermore, novel dosing algorithms may be developed for existing drugs that are still dosed as when they initially came on the market decades ago.
The use model-informed precision dosing may lead to more efficacy and less side effects, for example, reduced antimicrobial drug resistance or decreased incidence of febrile neutropenia for classic cytotoxic anticancer drugs. Furthermore, model-informed precision dosing may be used to reduce ‘financial toxicity’ of novel expensive drugs, for example by means individualized dose tapering.
For this Research Topic, we welcome Original Research, Reviews and Opinion letters on model-informed precision dosing. Both technical and clinical implementation research fall within the scope.
Keywords: Precision medicine, pharmacometrics, dose individualization, modelling and simulation, clinical pharmacometrics, artificial intelligence
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