Open Systems Pharmacology Community—An Open Access, Open Source, Open Science Approach to Modeling and Simulation in Pharmaceutical Sciences

作者：Jörg Lippert, Rolf Burghaus, Andrea N. Edginton, Sebastian Frechen, Mats O. Karlsson, Andreas Kovar, Thorsten Lehr, Peter Milligan, Valerie Nock, Sergej Ramusovic, Matthew Riggs, Stephan Schaller, Jan Schlender, Stephan Schmidt, Michaël Sevestre, Erik Sjögren, Juri Solodenko, Alexander Staab, Donato Teutonico · 发表于：CPT Pharmacometrics & Systems Pharmacology · 年份：2019 · DOI：10.1002/psp4.12473 · 被引用次数：110 · 研究领域：Diabetes Management and Research、Pharmaceutical studies and practices、3D Printing in Biomedical Research

Systems pharmacology integrates structural biological and pharmacological knowledge and experimental data, enabling dissection of organism and drug properties and providing excellent predictivity. The development of systems pharmacology models is a significant task requiring massive amounts of background information beyond individual trial data. The qualification of models needs repetitive demonstration of successful predictions. Open Systems Pharmacology is a community that develops, qualifies, and shares professional open source software tools and models in a collaborative open-science way. In recent years, systems pharmacology and its applications in pharmaceutical development have gained significant visibility and attention as an important pillar of model-informed drug (discovery and) development.1 Physiologically-based pharmacokinetics (PBPK) is just one of the many potential applications of systems pharmacology. Nevertheless, because of the generic relevance of pharmacokinetics in any pharmaceutical application, PBPK has seen the most rapid growth in terms of the number of organizations and scientists applying it and the published case studies. Regulatory use is documented in reviews of the European and US regulatory agencies2, 3 and has lately led both the US Food and Drug Administration (FDA)4 and European Medicines Agency5 to issue guidances for PBPK use. For some applications, PBPK has even become a recommended method (the FDA's Pharmaceutical Science and Clinical P...