Translational Medicine, Pharmacometrics, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.
CPT Pharmacometrics Syst Pharmacol. 2013 Feb 27;2(2):e29. doi: 10.1038/psp.2013.5.
The breakout session 2 of the European Medicines Agency/European Federation of Pharmaceutical Industries and Associations Modeling and Simulation (M&S) workshop focused on two topics: when and how M&S should be used and would be accepted by the authorities for the dose-regimen selection; and when and how M&S can be applied to register a dosing regimen without the need for a specific study. Each topic was introduced by an industry and regulatory perspective, followed by case examples for illustration (Table 1).CPT: Pharmacometrics & Systems Pharmacology (2013) 2, e29; doi:10.1038/psp.2013.5; advance online publication 27 February 2013.
欧洲药品管理局/欧洲制药工业和协会联合会建模与模拟（M&S）研讨会第 2 分会场重点讨论了两个主题：何时以及如何使用 M&S，以及监管机构何时以及如何接受 M&S 用于剂量方案选择；以及何时以及如何应用 M&S 来注册无需特定研究的给药方案。每个主题都分别从行业和监管角度进行了介绍，随后通过案例示例进行了说明（表 1）。CPT：药物代谢动力学与系统药理学（2013 年）2 期，e29；doi：10.1038/psp.2013.5；2013 年 2 月 27 日在线提前发表。
