Model-informed drug develop⁃ment(MIDD)is the application of a various math⁃ematical,statistical,and biological models to facilitate drug development,decision making and regulatory review.As a quantitative tool,MIDD ap...Model-informed drug develop⁃ment(MIDD)is the application of a various math⁃ematical,statistical,and biological models to facilitate drug development,decision making and regulatory review.As a quantitative tool,MIDD approaches allow an integration of information obtained from non-clinical studies and clinical trials in a drug development program.General understandings of the underlying biology,patho⁃physiology,and pharmacology can also be incor⁃porated into the model.MIDD is centered on knowledge and inferences generated from inte⁃grated models of the physicochemical character⁃istics of a molecule,its disposition in the body,and its mechanism of action,and how the drug might affect a disease from both an efficacy and a safety perspective.MIDD approaches have the potential to significantly streamline drug develop⁃ment,by improving clinical trial efficiency,opti⁃mizing dose and regimen and waive unneces⁃sary clinical studies.This presentation will use cases studies to demonstrate how to apply MIDD in early phase of clinical trials.展开更多
为了保证运维阶段桥梁结构安全,提升桥梁运维工作的效率,开展公路混凝土梁式桥运维阶段建筑信息模型(building information modeling,BIM)技术应用研究。在对公路桥梁现行编码体系进行扩展的基础上,提出1种参数化快速建模方法,以快速完...为了保证运维阶段桥梁结构安全,提升桥梁运维工作的效率,开展公路混凝土梁式桥运维阶段建筑信息模型(building information modeling,BIM)技术应用研究。在对公路桥梁现行编码体系进行扩展的基础上,提出1种参数化快速建模方法,以快速完成桥梁构件族的创建与整体模型的集成。借助Autodesk Revit软件应用程序编程接口(application programming interface,API),采用C#语言,开发公路混凝土梁式桥智慧运维状态评估系统,以实际工程应用进行验证分析。研究结果表明:全面统一的桥梁信息编码体系,能够提高桥梁信息统计与检索效率;提出的快速建模方法能够显著减少建模工作量,建模时间较传统建模方法可减少60%,并保证模型的准确性与规范性;运维状态评估系统能够实现养护数据的充分利用与桥梁评定工作的自动化,通过对桥梁运维信息的有效组织,实现服役性能的长期追踪,从而确保运营期桥梁结构状态安全稳定。研究结果可为公路混凝土梁式桥运维管理提供技术支撑,提升桥梁运维的数字化水平。展开更多
文摘Model-informed drug develop⁃ment(MIDD)is the application of a various math⁃ematical,statistical,and biological models to facilitate drug development,decision making and regulatory review.As a quantitative tool,MIDD approaches allow an integration of information obtained from non-clinical studies and clinical trials in a drug development program.General understandings of the underlying biology,patho⁃physiology,and pharmacology can also be incor⁃porated into the model.MIDD is centered on knowledge and inferences generated from inte⁃grated models of the physicochemical character⁃istics of a molecule,its disposition in the body,and its mechanism of action,and how the drug might affect a disease from both an efficacy and a safety perspective.MIDD approaches have the potential to significantly streamline drug develop⁃ment,by improving clinical trial efficiency,opti⁃mizing dose and regimen and waive unneces⁃sary clinical studies.This presentation will use cases studies to demonstrate how to apply MIDD in early phase of clinical trials.
