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Development and streamlining a validation and implementation workflow for model-informed precision dosing for biologicals and antimicrobials

It has been shown that in many specific patient populations, a standard dosing approach is not always warranting efficacy and safety. Some patients benefit from an adapted and personalized dosing strategy, in which pharmacokinetic target attainment is correlating with pharmacodynamics. Many pharmacokinetic studies, conducted in the field of antimicrobial therapy and anti-inflammatory biologicals, of us and others allowed to model exposure and PK parameters with integration of patient characteristics explaining inter- and intrapatient variability.  The next step is to personalize dosing strategies based on these models, so that pharmacokinetic target attainment is ensured, which is referred to as ‘Model-Informed Precision Dosing’ (MIPD). The goal of this application is to develop and software in order to allow MIPD for infliximab (in the setting of inflammatory bowel disease), ceftriaxone and posaconazole (in the setting of critically ill patients admitted for severe pneumonia or invasive fungal infection). Next to this, a generic and broad scale applicable validation process, including internal and (multicentric retro- and prospective) external validation, will be developed. Both objectives, development and validation of MIPD software, are key-elements to bring personalized dosing to the bedside, and will serve as proof-of-concept to enable precision dosing for many other biologicals and antimicrobials.
Date:1 Oct 2020 →  Today
Keywords:Model-informed precision dosing, Clinical decision support software tool, Inflammatory bowel diseases, Severe bacterial infections, Pharmacometrics
Disciplines:Pharmacokinetics, Development of bioinformatics software, tools and databases, Computational biomodelling and machine learning