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- W2220969173 abstract "Modelling and simulation are acknowledged methodologies used by industry, academia, and regulatory agencies to support and optimize clinical trials and are used as data-analysis tools during various stages of the drug-development process. Conventional modelling and simulation tools are data driven, and besides their potential in clinical applications, particularly in establishing therapeutic dosage regimens and addressing factors responsible for the observed variability in drug behaviour in a certain population, these tools are unsuitable for use beyond the experimental data, e.g., for age extrapolation to neonates. In contrast, physiology-based pharmacokinetic (PBPK) models are mechanistic models that are independent of the measured concentrations and are based instead on the known anatomy and physiology of the living organism being modelled. They can also be used as a predictive tool to explore the changes in drug behaviour a priori, e.g., for age extrapolation, and are considered to be superior to classical compartmental models in this respect. This report will explore the potential contributions of PBPK models to paediatric and neonatal clinical trials, will give a brief overview of the basic concepts of PBPK modelling and, where it is appropriate, will provide an overview of examples of such models reported in the published literature." @default.
- W2220969173 created "2016-06-24" @default.
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- W2220969173 date "2014-01-01" @default.
- W2220969173 modified "2023-10-16" @default.
- W2220969173 title "Modelling and Simulation to Support Neonatal Clinical Trials" @default.
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- W2220969173 doi "https://doi.org/10.1159/000365025" @default.
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