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基于FDA现场检查报告的药物临床试验质量管理分析
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作者 张茹馨 蔡林柏闻 +1 位作者 余美辰 程国华 《中国医药科学》 2025年第16期163-167,共5页
目的探究美国食品药品监督管理局(FDA)新药临床试验现场检查的重点,提出提高新药临床试验质量的方法和建议。方法收集2019—2023年FDA新药现场检查发现的问题,参考《药品注册核查要点与判定原则(药物临床试验)(试行)》对问题进行分类和... 目的探究美国食品药品监督管理局(FDA)新药临床试验现场检查的重点,提出提高新药临床试验质量的方法和建议。方法收集2019—2023年FDA新药现场检查发现的问题,参考《药品注册核查要点与判定原则(药物临床试验)(试行)》对问题进行分类和统计分析。结果217个递交原始新药申请的新药存在违反药品注册核查要点与判定原则的不合格项共计758项,其中在临床试验实施过程方面存在不合格项630项(占比83.1%);在申办方职责方面存在不合格项59项(占比7.8%);在试验用药品管理方面存在不合格项31项(占比4.1%)。结论2019—2023年FDA新药现场检查重点在临床试验数据记录和报告、方案依从性、安全性信息记录与报告以及试验用药品管理方面,建议通过强化药物临床试验质量管理规范培训、优化监查机制、完善申办方质量管理体系以及推动信息化和人工智能应用,全面提升临床试验质量与合规性。 展开更多
关键词 药物临床试验 美国食品药品监督管理局 现场检查 质量管理
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Simulation experiment of AE-based localization damage and deformation characteristic on covering rock in mined-out area 被引量:6
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作者 Sheng-jun Miao Xing-ping Lai +1 位作者 Xing-guang Zhao Fen-hua Ren 《International Journal of Minerals,Metallurgy and Materials》 SCIE EI CAS CSCD 2009年第3期255-260,共6页
The localization damage and deformation characteristics of multiple rock in mined-out area under thick soil layer were investigated by acoustic emission (AE)-based physical similar simulation experiment and damage t... The localization damage and deformation characteristics of multiple rock in mined-out area under thick soil layer were investigated by acoustic emission (AE)-based physical similar simulation experiment and damage test combined with the AE theory on rock damage. During different mining courses, the degree of wall rock suffered from mining disturbed process in mined-out area was different, so did the AE density of initial damage and fracture. Some characteristic parameters, including large events, total events, and energy rate, presented fluctuations with temporal and spatial change and take on a certain extent statistic relation. Subsequently, the percent of damage degree was defined and divided into 4 stages, and the localization damage and deformation characteristics of surrounding rock in mined-out area and coal pillars were analyzed quantitatively. 展开更多
关键词 acoustic emission soil layer underground mine rock damage in-site monitoring
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NEW METHOD TO MEASURE PISTON SKIRT DIMENSIONS 被引量:4
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作者 QinYuexia HuDejin 《Chinese Journal of Mechanical Engineering》 SCIE EI CAS CSCD 2004年第3期368-371,共4页
The measurement of the middle-convex and varying ellipse profile of a pistonskirt is a key technology because of its complex profile and high precision. Generally, a piston ismeasured on special device after it is mac... The measurement of the middle-convex and varying ellipse profile of a pistonskirt is a key technology because of its complex profile and high precision. Generally, a piston ismeasured on special device after it is machined. High accuracy can be achieved through this off-linemeasurement, but the result diverges from the actual dimension. Therefore, a no-contact in-sitemeasurement system is proposed. A laser displacement meter is used to measure the profile of thepiston skirt. A computer connected to the meter is used to process the measured data. A regressionanalysis method is used to process the ellipse section data. The method of moving average is used toprocess the middle-convex curve data. By using the given system, high measurement accuracy can begained, and the production requirement is met. 展开更多
关键词 Middle-convex and varying ellipse piston No-contact in-site measurement
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The Dynamic Characteristic Experimental Method on the Composite Foundation with Rigid-Flexible Compound Piles 被引量:2
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作者 Jihui Ding Weiyu Wang +2 位作者 Tuo Zhao Junhui Feng Panxing Zhang 《Open Journal of Civil Engineering》 2013年第2期94-98,共5页
Based on the idea of optimization design of pile type, the composite foundations, which include cememt-flyash-gaavel (for short CFG) long piles and cement-soil (for short CS) short piles, and CS piles with CFG core as... Based on the idea of optimization design of pile type, the composite foundations, which include cememt-flyash-gaavel (for short CFG) long piles and cement-soil (for short CS) short piles, and CS piles with CFG core as well, are formed. The method of the site dynamic characteristic tests of the composite foundations is discussed. The test results show that fireworks bomb may replace demolitions as the vibration resource. Vibration time is about 0.1 sec. Horizontal vibration major frequency is at 22.476 - 56.436 Hz, and vertical vibration major frequency is at 15.538 - 55.884 Hz. The pile arrangements of the composite foundation in the same site have more effect on the acceleration peak value. From the point of vibration, the anti-seismic effect of the CS piles with CFG core is better than others. 展开更多
关键词 Cement-Soil PILES Cememt-Flyash-Gaavel PILES Composite FOUNDATION Dynamic Characteristic in-site Test
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计算机天然采光模拟插件在树木遮挡空间的应用研究 被引量:2
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作者 吴蔚 汤晋 《照明工程学报》 2020年第2期138-144,共7页
建筑物周围的树木会对建筑低层的室内采光造成很大影响。然而,作为一个形状和材质复杂多变的三维体,目前的计算机光模拟软件较难精确模拟出室外树木对室内光环境的影响。本文选择两款较为流行的计算机天然光模拟插件DIVA和Honeybee,通... 建筑物周围的树木会对建筑低层的室内采光造成很大影响。然而,作为一个形状和材质复杂多变的三维体,目前的计算机光模拟软件较难精确模拟出室外树木对室内光环境的影响。本文选择两款较为流行的计算机天然光模拟插件DIVA和Honeybee,通过实地测量与比较性研究,从静态和全年动态天然光模拟两方面探讨这两款插件在树木遮挡空间的适用性和可靠性。 展开更多
关键词 计算机光模拟插件 树木遮挡空间 天然采光 实地测量 比较分析
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