Drug-disease modeling in the pharmaceutical industry - where mechanistic systems pharmacology and statistical pharmacometrics meet

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences
Gabriel HelmlingerDonald Stanski

Abstract

Modeling & simulation (M&S) methodologies are established quantitative tools, which have proven to be useful in supporting the research, development (R&D), regulatory approval, and marketing of novel therapeutics. Applications of M&S help design efficient studies and interpret their results in context of all available data and knowledge to enable effective decision-making during the R&D process. In this mini-review, we focus on two sets of modeling approaches: population-based models, which are well-established within the pharmaceutical industry today, and fall under the discipline of clinical pharmacometrics (PMX); and systems dynamics models, which encompass a range of models of (patho-)physiology amenable to pharmacological intervention, of signaling pathways in biology, and of substance distribution in the body (today known as physiologically-based pharmacokinetic models) - which today may be collectively referred to as quantitative systems pharmacology models (QSP). We next describe the convergence - or rather selected integration - of PMX and QSP approaches into 'middle-out' drug-disease models, which retain selected mechanistic aspects, while remaining parsimonious, fit-for-purpose, and able to address variability and th...Continue Reading

Citations

Sep 25, 2018·Journal of Clinical Pharmacology·Michael NeelyAndrea Edginton
Jun 18, 2019·CPT: Pharmacometrics & Systems Pharmacology·Matthew FidlerWenping Wang
Jul 4, 2020·CPT: Pharmacometrics & Systems Pharmacology·Richard J SovéAleksander S Popel
May 16, 2018·CPT: Pharmacometrics & Systems Pharmacology·Mirjam N TrameCynthia J Musante
Jun 4, 2019·Frontiers in Pharmacology·Pantelis NatsiavasVassilis Koutkias

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