随着科学技术的进步,越来越多先进的自动化设备和计算机化系统进入良好实验室规范(GLP)领域,在享受着高新技术手段带来的高效和便利之时,实验室数据完整性管理也不断受到挑战,主要就是科学技术现代化水平不断升级与实验室内部管理手段...随着科学技术的进步,越来越多先进的自动化设备和计算机化系统进入良好实验室规范(GLP)领域,在享受着高新技术手段带来的高效和便利之时,实验室数据完整性管理也不断受到挑战,主要就是科学技术现代化水平不断升级与实验室内部管理手段应对不足的矛盾。目前,多个重要国家和组织陆续发出了计算机化系统验证和数据完整性管理的法规和指南,并积累了丰富的监管经验。本文梳理并总结了经济合作与发展组织(Organization for Economic Co-operation and Development,OECD)、国际制药工程协会(International Society of Pharmaceutical Engineers,ISPE)、国际药品认证合作组织(Pharmaceutical Inspection Co-operation Scheme,PIC/S)、欧洲原料药委员会(Active Pharmaceutical Ingredients Committee,APIC)等重要机构的数据完整性和计算机化系统要求,结合生态毒理GLP机构的发展需求,根据风险质量管理、计算机化系统验证和数据完整性管理的要求,建立了一种基于数据完整性的计算机化系统分级管理策略。通过信息收集、分类分级、措施评估和措施管理四步法,提出了计算机化系统管理中数据完整性措施的管理思路,该方法具有集约化、策略化和科学化的特点,有助于生态毒理GLP机构提升计算机化系统应用和管理能力,推进我国GLP机构国际化发展进程。展开更多
To solve the problem of advanced digital manufacturing technology in the practical application, a knowledge engineering technology was introduced into the computer numerical control(CNC) programming. The knowledge acq...To solve the problem of advanced digital manufacturing technology in the practical application, a knowledge engineering technology was introduced into the computer numerical control(CNC) programming. The knowledge acquisition, knowledge representation and reasoning used in CNC programming were researched. The CNC programming system functional architecture of impeller parts based on knowledge based engineering(KBE) was constructed. The structural model of the general knowledge-based system(KBS) was also constructed. The KBS of CNC programming system was established through synthesizing database technology and knowledge base theory. And in the context of corporate needs, based on the knowledge-driven manufacturing platform(i.e. UG CAD/CAM), VC++6.0 and UG/Open, the KBS and UG CAD/CAM were integrated seamlessly and the intelligent CNC programming KBE system for the impeller parts was developed by integrating KBE and UG CAD/CAM system. A method to establish standard process templates was proposed, so as to develop the intelligent CNC programming system in which CNC machining process and process parameters were standardized by using this KBE system. For the impeller parts processing, the method applied in the development of the prototype system is proven to be viable, feasible and practical.展开更多
文摘随着科学技术的进步,越来越多先进的自动化设备和计算机化系统进入良好实验室规范(GLP)领域,在享受着高新技术手段带来的高效和便利之时,实验室数据完整性管理也不断受到挑战,主要就是科学技术现代化水平不断升级与实验室内部管理手段应对不足的矛盾。目前,多个重要国家和组织陆续发出了计算机化系统验证和数据完整性管理的法规和指南,并积累了丰富的监管经验。本文梳理并总结了经济合作与发展组织(Organization for Economic Co-operation and Development,OECD)、国际制药工程协会(International Society of Pharmaceutical Engineers,ISPE)、国际药品认证合作组织(Pharmaceutical Inspection Co-operation Scheme,PIC/S)、欧洲原料药委员会(Active Pharmaceutical Ingredients Committee,APIC)等重要机构的数据完整性和计算机化系统要求,结合生态毒理GLP机构的发展需求,根据风险质量管理、计算机化系统验证和数据完整性管理的要求,建立了一种基于数据完整性的计算机化系统分级管理策略。通过信息收集、分类分级、措施评估和措施管理四步法,提出了计算机化系统管理中数据完整性措施的管理思路,该方法具有集约化、策略化和科学化的特点,有助于生态毒理GLP机构提升计算机化系统应用和管理能力,推进我国GLP机构国际化发展进程。
文摘目的:开发和验证乳腺癌患者新发心血管疾病(cardiovascular disease,CVD)的3年预测模型。方法:基于内蒙古区域医疗数据,纳入接受抗肿瘤治疗的18岁以上乳腺癌女性患者。多因素Fine&Gray模型纳入预测因子后,使用Lasso回归筛选变量,在训练集上拟合Cox比例风险、Logistic回归、Fine&Gray、随机森林和XGBoost模型,在测试集上分别用受试者工作特征(receiver operating characteristics,ROC)曲线下面积(area under the curve,AUC)和校准曲线评价模型区分度和校准度。结果:共纳入19325例接受抗肿瘤治疗的乳腺癌患者,平均年龄(52.76±10.44)岁,中位随访时间1.18年[四分位距(interquartile range,IQR):2.71]。7856例患者(40.65%)在乳腺癌诊断3年内发生CVD。Lasso回归筛选的预测因子为乳腺癌诊断年龄、居住地国内生产总值(gross domestic product,GDP)、肿瘤分期、高血压、缺血性心脏病及脑血管疾病既往史、手术类型、化疗类型、放疗类型。不考虑生存时间时,XGBoost模型的AUC显著高于随机森林模型[0.660(95%CI:0.644~0.675)vs.0.608(95%CI:0.591~0.624),P<0.001]和Logistic回归[0.609(95%CI:0.593~0.625),P<0.001],Logistic回归和XGBoost模型的校准度更好。考虑生存时间时,Cox比例风险模型和Fine&Gray模型的AUC差异无统计学意义[0.600(95%CI:0.584~0.616)vs.0.615(95%CI:0.599~0.631),P=0.188],但Fine&Gray模型的校准度更好。结论:基于区域医疗数据建立乳腺癌新发CVD的预测模型具有可行性。不考虑生存时间时,Logistic回归和XGBoost模型的预测性能更好;考虑生存时间时,Fine&Gray模型的预测性能更好。
基金Project(12ZT14)supported by the Natural Science Foundation of Shanghai Municipal Education Commission,China
文摘To solve the problem of advanced digital manufacturing technology in the practical application, a knowledge engineering technology was introduced into the computer numerical control(CNC) programming. The knowledge acquisition, knowledge representation and reasoning used in CNC programming were researched. The CNC programming system functional architecture of impeller parts based on knowledge based engineering(KBE) was constructed. The structural model of the general knowledge-based system(KBS) was also constructed. The KBS of CNC programming system was established through synthesizing database technology and knowledge base theory. And in the context of corporate needs, based on the knowledge-driven manufacturing platform(i.e. UG CAD/CAM), VC++6.0 and UG/Open, the KBS and UG CAD/CAM were integrated seamlessly and the intelligent CNC programming KBE system for the impeller parts was developed by integrating KBE and UG CAD/CAM system. A method to establish standard process templates was proposed, so as to develop the intelligent CNC programming system in which CNC machining process and process parameters were standardized by using this KBE system. For the impeller parts processing, the method applied in the development of the prototype system is proven to be viable, feasible and practical.
