Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, Florida, USA.
Center for Drug Evaluation and Safety, Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, Florida, USA.
CPT Pharmacometrics Syst Pharmacol. 2019 Jun;8(6):352-355. doi: 10.1002/psp4.12425. Epub 2019 Jun 9.
The application of modeling and simulation (M&S) tools to biological, physiological, and clinical data has great potential to enhance drug development and regulatory decision making. The strategic development of multidisciplinary projects aimed at integrating methodologies from different disciplines may bridge between preclinical and clinical drug development as well as between academic curiosity and clinical practice. Herein we review the history and present the state of M&S approaches as well as our vision for future challenges and applications.
建模和模拟 (M&S) 工具在生物、生理和临床数据中的应用具有极大的潜力,可以增强药物开发和监管决策。旨在整合来自不同学科的方法的多学科项目的战略发展可以在临床前和临床药物开发以及学术好奇心和临床实践之间架起桥梁。本文回顾了 M&S 方法的历史和现状,并展望了未来的挑战和应用。