In European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences
Quantitative systems pharmacology (QSP) models are an important facet of pharmaceutical and clinical research as they combine mechanistic models of physiology in health and disease with pharmacokinetics/pharmacodynamics to predict systems-level effects. The quantitative clinical pharmacology toolbox has traditionally included both mechanistic modeling and population approaches, collectively called pharmacometrics, but the current landscape requires the optimization and use of multiple models together. Here, we explore several case studies in drug development that exemplify three approaches for using QSP and pharmacometrics models together - parallel synchronization, cross-informative use, and sequential integration. While these approaches are increasingly applied in drug development, achieving a true convergence of QSP and pharmacometrics that fully exploits their synergy will require new tools and methods that enable greater technical integration, plus growing scientists with diverse modeling expertise that enable cross-discipline strategy. These could include extensions of existing methods used in each approach as well as additional tools, including machine learning models, data-at-scale, end-to-end computation platforms, and real-time analytics.
Joshi Amita, Ramanujan Saroja, Jin Jin Y
2023-Jan-10
Quantitative system pharmacology, pharmacometrics, quantitative pharmacology
