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Model-informed drug development (MIDD) refers to the application of a wide range of quantitative models in drug development to facilitate the decision-making process. MIDD uses quantitative models to describe the relationship between exposure to drugs (pharmacokinetics) and changes in drugs from exposure ...

Model-informed drug development (MIDD) refers to the application of a wide range of quantitative models in drug development to facilitate the decision-making process. MIDD uses quantitative models to describe the relationship between exposure to drugs (pharmacokinetics) and changes in drugs from exposure (pharmacodynamics). It also uses disease models to describe the progression of disease over time, placebo effects and the relationship between biomarkers and clinical outcomes. Model-informed approaches have revolutionized drug discovery and development. MIDD is now formally recognized as an important enabler of efficient and effective drug development by the main regulatory agencies (FDA, EMA, PMDA, and CFDA).

Pharmacometrics is the core of MIDD, aimed at establishing models to provide guidance and decision support in drug development such as efficacy comparisons, dosage regimen optimization and endpoint analysis. Over the last decade, there is an increased application of pharmacometric methodologies in drug development and applied pharmacotherapy by industry, academia and especially regulatory agencies. This Research Topic focuses on providing a platform for pharmacometricians to share their cutting-edge works and for academic scientists to share new modelling strategies and methodologies.

The aim of the current Research Topic is to cover promising, recent, and novel research trends in model-informed drug discovery and development. Areas to be covered in this Research Topic may include, but are not limited to:

• Model-informed Drug Development,

• Model-informed Precision Dosing Quantitative Systems Pharmacology,

• Physiologically-based Pharmacokinetics Model,

• Systems Biology Model

• Machine-learning

• Pharmacoeconomics

• Chemoinformatics

• Clinical reports

• Evidence-based mechanopharmacology

To be considered for review in the specialty section Translational Pharmacology submissions cannot be based on purely in silico work.

Keywords: Pharmacometrics, Drug development, Clinical observations, Advanced analysis tools, Cellular and molecular mechanics


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