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AN ANALYSIS OF ACOUSTIC CHARACTERISTICS OFCLEFT PALATE SPEECH WITH COMPUTERIZED SPEECH SIGNAL PROCESSING SYSTEM 被引量:1
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作者 李锦峰 刘建华 《Journal of Pharmaceutical Analysis》 CAS 1996年第2期162-165,共4页
The acoustic characteristics or the chinese vowels of 24 children with cleft palate and 10 normal control children were analyzed by computerized speech signal processing system (CSSPS),and the speech articulation was ... The acoustic characteristics or the chinese vowels of 24 children with cleft palate and 10 normal control children were analyzed by computerized speech signal processing system (CSSPS),and the speech articulation was judged with Glossary of clert palate speech(GCPS).The listening judgement showed that the speech articulation was significantly different between the two groups(P<0.01).The objective quantitative measurement suggested that the formant pattern(FP)of vowels in children with cleft palate was different from that of normal control children except vowel[a](P< 0.05).The acoustic vowelgraph or the Chinese vowels which demonstrated directly the relationship of vocal space and speech perception was stated with the first formant frequence(F1)and the second formant frequence(F2).The authors conclude that the values or F1 and F2 point out the upward and backward tongue movement to close the clert, which reflects the vocal characteristics of trausmission of clert palate speech. 展开更多
关键词 cleft palate speech the Chinese vowels the formant pattern the speech articulation computerized speech singnal processing system
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COMPUTER SIMULATION OF DIRECT TORQUE CONTROL SYSTEM
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作者 Hu Yuwen Xu Yue(Department of Automatic Control,NUAA 29 Yudao Street,Nanjing 210016,P.R.China) 《Transactions of Nanjing University of Aeronautics and Astronautics》 EI 1994年第2期189-193,共5页
Computer simulation researches on Direct Torque Control System (DTC) are to be done. That fact is demonstrated:at high speed,the operating property of an induction motor is very good,almost the same as fieldoriented c... Computer simulation researches on Direct Torque Control System (DTC) are to be done. That fact is demonstrated:at high speed,the operating property of an induction motor is very good,almost the same as fieldoriented control system fat low speed (for example: below 2-3Hz), the operating property of a motor is getting worse,and the stator resistance R1 of the motor must be compensated. If compensation precision gets 5 %,the operating property of the motor will be greatly improved. 展开更多
关键词 computerIZED SIMULATION SPEED CONTROL system motors
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Computer aided analysis system for drilling
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作者 li yanzao china uniuersity of geosciences 《西部探矿工程》 CAS 1995年第5期33-37,共5页
COMPUTERAIDEDANALYSISFORDRILLINGLiYanzaoChinaUniversityofGeosciencesBeijingl00083,ChinaCOMPUTERAIDEDANALYSIS... COMPUTERAIDEDANALYSISFORDRILLINGLiYanzaoChinaUniversityofGeosciencesBeijingl00083,ChinaCOMPUTERAIDEDANALYSISFORDRILLINGLiYanz... 展开更多
关键词 computerIZED analysis system critical BIT WEIGHT and dritical ROTARY speed friction resistance distinguishing formation DISCERNMENT of BIT condition
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基于计算机的蓄热式加热炉燃烧过程控制系统研究
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作者 刘一鸥 《工业加热》 CAS 2024年第10期31-34,共4页
随着工业生产和能源需求的不断增长,工业领域正经历着巨大的变革。在此背景下,热处理和加热炉的设计和操作变得至关重要,因为它们直接影响到生产过程的效率和环境可持续性。蓄热式加热炉是热处理工业中的重要设备,广泛应用于钢铁、有色... 随着工业生产和能源需求的不断增长,工业领域正经历着巨大的变革。在此背景下,热处理和加热炉的设计和操作变得至关重要,因为它们直接影响到生产过程的效率和环境可持续性。蓄热式加热炉是热处理工业中的重要设备,广泛应用于钢铁、有色金属和其他行业。其燃烧过程的控制对产品质量、能源利用效率和环境保护至关重要。对基于计算机的蓄热式加热炉燃烧过程控制系统进行了深入研究和分析。探讨了蓄热式加热炉结构以及特点,分析蓄热式加热炉燃烧控制策略,并从温度前馈双交叉限幅燃烧控制系统设计以及板坯温度预报模型介绍结合了基于计算机控制的蓄热式加热炉设计方法,能够帮助工业企业以应对不断变化的工业需求和环境法规,推动热处理工业的可持续发展。 展开更多
关键词 蓄热式加热炉 燃烧过程 计算机控制 系统设计
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药品色谱检测中的数据完整性问题探讨
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作者 沈丽欢 《上海医药》 CAS 2024年第3期59-63,共5页
当前药品色谱检测中的数据完整性问题主要包括计算机化系统的访问管理、非合规测试(如单针进样、中止序列)、数据的再处理和手动积分、元数据和审计追踪、超标结果管理等,这些问题可能会影响公司产品质量的可信度,严重的可能导致上市药... 当前药品色谱检测中的数据完整性问题主要包括计算机化系统的访问管理、非合规测试(如单针进样、中止序列)、数据的再处理和手动积分、元数据和审计追踪、超标结果管理等,这些问题可能会影响公司产品质量的可信度,严重的可能导致上市药品的频繁召回。本文回顾国家药品监督管理局食品药品审核查验中心发布的2017年度、2021年度药品检查工作报告和美国食品药品管理局(FDA)官网近2年公布的警告信中关于药品色谱检测中的数据完整性问题,并讨论了规避上述问题的措施。 展开更多
关键词 数据完整性 计算机化系统 色谱检测
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基于重组蛋白新冠疫苗生产现场的检查要点分析
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作者 王菁华 曾雅婷 +1 位作者 周星妮 伦得智 《广东化工》 CAS 2024年第6期75-77,共3页
新冠疫情使人们普遍认识到疫苗对于公共卫生的重要性,重组蛋白疫苗作为重要的疫苗类型,因其保护效力和安全性的优势受到广泛关注。重组蛋白疫苗的生产一般包括种子库的建立和检定、原液生产、制剂生产、质量检验等过程。现场检查中需要... 新冠疫情使人们普遍认识到疫苗对于公共卫生的重要性,重组蛋白疫苗作为重要的疫苗类型,因其保护效力和安全性的优势受到广泛关注。重组蛋白疫苗的生产一般包括种子库的建立和检定、原液生产、制剂生产、质量检验等过程。现场检查中需要重点关注蛋白生物活性的工艺控制,随着重组蛋白疫苗关注度的提升,生产现场检查规范的建立与完善成为一个重要课题。 展开更多
关键词 重组蛋白 新冠疫苗 原液生产现场检查 制剂生产现场检查 计算机化系统
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A Framework for Cloud Validation in Pharma
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作者 Pravin Ullagaddi 《Journal of Computer and Communications》 2024年第9期103-118,共16页
The pharmaceutical industry’s increasing adoption of cloud-based technologies has introduced new challenges in computerized systems validation (CSV). This paper explores the evolving landscape of cloud validation in ... The pharmaceutical industry’s increasing adoption of cloud-based technologies has introduced new challenges in computerized systems validation (CSV). This paper explores the evolving landscape of cloud validation in pharmaceutical manufacturing, focusing on ensuring data integrity and regulatory compliance in the digital era. We examine the unique characteristics of cloud-based systems and their implications for traditional validation approaches. A comprehensive review of current regulatory frameworks, including FDA and EMA guidelines, provides context for discussing cloud-specific validation challenges. The paper introduces a risk-based approach to cloud CSV, detailing methodologies for assessing and mitigating risks associated with cloud adoption in pharmaceutical environments. Key considerations for maintaining data integrity in cloud systems are analyzed, particularly when applying ALCOA+ principles in distributed computing environments. The article presents strategies for adapting traditional Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) models to cloud-based systems, highlighting the importance of continuous validation in dynamic cloud environments. The paper also explores emerging trends, including integrating artificial intelligence and edge computing in pharmaceutical manufacturing and their implications for future validation strategies. This research contributes to the evolving body of knowledge on cloud validation in pharmaceuticals by proposing a framework that balances regulatory compliance with the agility offered by cloud technologies. The findings suggest that while cloud adoption presents unique challenges, a well-structured, risk-based approach to validation can ensure the integrity and compliance of cloud-based systems in pharmaceutical manufacturing. 展开更多
关键词 computerized systems Validation Risk-Based Approach Data Integrity Pharmaceutical Manufacturing Cloud Validation
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会计电算化到ERP系统中的财务管理过程分析
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作者 朱云 《市场周刊》 2024年第11期123-126,共4页
随着信息技术的快速发展和应用,会计电算化和企业资源规划(ERP)系统在财务管理领域的应用已经成为一种趋势。会计电算化将传统的手工会计工作转变为计算机自动化处理,提高了财务数据的准确性和效率。ERP系统通过整合企业各个部门的信息... 随着信息技术的快速发展和应用,会计电算化和企业资源规划(ERP)系统在财务管理领域的应用已经成为一种趋势。会计电算化将传统的手工会计工作转变为计算机自动化处理,提高了财务数据的准确性和效率。ERP系统通过整合企业各个部门的信息,实现了企业资源的统一管理和监控。文章主要论述会计电算化的概念,讨论会计电算化与ERP系统之间的差异性,并提出ERP技术背景下财务系统管理的创新策略,这有助于进一步优化和加强财务管理流程,为相关领域的研究和实践提供一定的参考和借鉴价值。 展开更多
关键词 会计电算化 ERP系统 财务管理
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Development of a Framework for Equipment Health Management in the Mining Industries in Zambia
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作者 Tobias Njobvu Terence Malama 《World Journal of Engineering and Technology》 2024年第3期665-694,共30页
The Zambian mining industry is crucial to the national economy but struggles with inconsistent equipment maintenance practices. This study developed an Equipment Maintenance Management Framework (EMMF) tailored to the... The Zambian mining industry is crucial to the national economy but struggles with inconsistent equipment maintenance practices. This study developed an Equipment Maintenance Management Framework (EMMF) tailored to the industry’s needs. Using surveys, interviews, and on-site visits at eight major mining companies, we identified significant variations in maintenance strategies, CMMS usage, and reliability engineering. The EMMF prioritizes predictive maintenance, efficient CMMS implementation, ongoing training, and robust reliability engineering to shift from reactive to proactive maintenance. We recommend adopting continuous improvement practices and data-driven decision-making based on performance metrics, with a phased EMMF implementation aligning maintenance with strategic business objectives. This framework is poised to enhance operational efficiency, equipment reliability, and safety, fostering sustainable growth in the Zambian mining sector. 展开更多
关键词 Equipment Maintenance Management Framework (EMMF) computerized Maintenance Management system (CMMS) Preventive Maintenance Predictive Maintenance Data Analytics
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Development and application of a closed-loop medication administration system in University of Hongkong-Shenzhen Hospital 被引量:1
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作者 Lan-Ping Shi Chun-Hong Liu +4 位作者 Jian-Fen Cao Yan Lu Fan-Xin Xuan Yu-Ting Jiang Jin-Yang Zhou 《Frontiers of Nursing》 CAS 2018年第2期105-109,共5页
Objective: This study aimed to develop and apply a closed-loop medication administration system in a hospital in order to reduce medication administration errors (MAEs).Methods: The study was imple... Objective: This study aimed to develop and apply a closed-loop medication administration system in a hospital in order to reduce medication administration errors (MAEs).Methods: The study was implemented in four pilot general wards. We used a before-and-after design to collect oral medication administration times before and after the implementation of the closed-loop medication administration system, evaluated MAE alert logs after the intervention, and conducted a survey of the nurses1 satisfaction with the system in the pilot wards.Results: (a) Nursing time of oral medication administration: before the adoption of the closed-loop medication administration system, the average nursing time was 31.56 ± 10.88 minutes (n = 78); after the adoption of the system, the time was 18.74 ± 5.60 minutes (n = 54). Independent sample Mests showed a significant difference between two groups(t= 8.85, P 〈0.00). (b) Degree of nurses’ satisfaction with the closed-loop medication administration system: 60.00% (n = 42) of nurses considered the system to be helpful for their work and nearly half of the nurses (47.14%, n = 33) believed that the system could facilitate clinical work and reduce workload; 51.43% {n = 36) believed that the system could reduce checking time and enhance work efficiency; 82.86% (n = 58) believed that the system was helpful in improving checking accuracy to reduce MAEs and ensure patient safety. More than 60% of the nurses considered the system to be a method that could help to track MAEs to improve nursing quality, (c) The MAE alert logs during observation period: it revealed only 27 alerts from the repeated scans of 3,428 instances of medication administration.Conclusions: The nurses were satisfied with the closed-loop medication administration system because it improved their work efficiency and reduced their workload. The current investigation was limited by time; therefore, further research is needed to more closely examine the relationship between the system and MAEs. 展开更多
关键词 medication error medication administration closed-loop system computerized physician order entry system
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Intelligent Support System for E-Health
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作者 Larysa GLOBA Ivan ISHCHENKO Andrii ZAKHARCHUK 《通讯和计算机(中英文版)》 2017年第1期46-52,共7页
关键词 电子信息资源 智能支持系统 数据预处理方法 联网技术 健康监测系统 电子监控系统 模糊逻辑 数据处理
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城市轨道交通车站配线能力计算系统 被引量:3
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作者 缪道平 陈阳 吴思遐 《现代城市轨道交通》 2023年第7期1-6,共6页
为解决目前城市轨道交通车站配线能力计算存在的计算方法及取用参数等差异大、计算过程繁杂耗时长等问题,文章在研究确定城市轨道交通车站配线能力计算输入条件(如道岔侧向过岔速度、道岔解锁及办理进路时间、设备确认时间、列车加速度... 为解决目前城市轨道交通车站配线能力计算存在的计算方法及取用参数等差异大、计算过程繁杂耗时长等问题,文章在研究确定城市轨道交通车站配线能力计算输入条件(如道岔侧向过岔速度、道岔解锁及办理进路时间、设备确认时间、列车加速度等主要计算参数,以及列车在各项作业中的出清点位置和走行距离)的基础上,研制城市轨道交通车站配线能力计算系统,介绍其功能、模块设计及应用效果,以期实现配线能力计算的标准化、电算化及出图的标准化,从而提高计算的统一性、准确性及效率。 展开更多
关键词 城市轨道交通 车站 配线能力计算系统 标准化 电算化
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基于FMECA的LIMS风险评估在药物安全性评价流程中的应用研究
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作者 张曦 刘晓萌 +3 位作者 赵曼曼 于连东 耿兴超 谢寅 《中国药事》 2023年第12期1421-1430,共10页
目的:探讨药物安全评价研究机构对实验室信息管理系统(LIMS)实施风险评估的方法,并基于评估结果制定措施降低风险,确保研究质量。方法:采用“故障模式、影响和危害性分析”(FMECA)方法,对LIMS实施整体的风险评估。首先确定风险评估的目... 目的:探讨药物安全评价研究机构对实验室信息管理系统(LIMS)实施风险评估的方法,并基于评估结果制定措施降低风险,确保研究质量。方法:采用“故障模式、影响和危害性分析”(FMECA)方法,对LIMS实施整体的风险评估。首先确定风险评估的目的、范围、依据和评估工具,并建立风险评估组织,根据风险评估流程对LIMS实施的整体合规性风险评估过程进行梳理。结果与结论:通过对系统实施的整体合规性评估明确了风险来源,发现了会影响研究质量的风险,并制定了降低风险措施以保证系统的整体合规要求,进一步提升了药物安全评价研究的数据质量。FMECA方法可应用在用于药物安全性评价研究流程中的LIMS,对提升数据质量有很好的帮助。 展开更多
关键词 数据质量 计算机化系统 风险评估 实验室信息管理系统
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The Design of the Fuzzy Inference System for the Determination of Attention
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作者 Hye Jin Kim Sun K. Yoo 《Engineering(科研)》 2013年第5期58-62,共5页
In this study, by using the response speed and the number of errors resulting from the children’s concentration test through the fuzzy inference system and comparing it to the theta which is one of the EEG’s paramet... In this study, by using the response speed and the number of errors resulting from the children’s concentration test through the fuzzy inference system and comparing it to the theta which is one of the EEG’s parameter to find the level of concentration. Targeting 21(Male 12, Female 9) healthy children between the ages of 10 - 14, the test was conducted one time with a duration of 14 minutes. For the first 5 minutes the children were listening to the Bach’s Air on a G string having a steady state and the next 9 minutes the children were subjected to the external stimuli audiogenic stimulation that induces attention concentration. When the number 3 was heard, children were subjected to press down on the spacebar to check the response speed and the number of errors. By conducting computerized neurocognitive function test to compare the theta wave related to the concentration with the response speed and the number of errors that determines the attention concentration through the fuzzy system, the data from 15 children out of 21 have shown the results for the concentration. In order to check the concentration level, a fuzzy inference system which was designed by the user could be used. 展开更多
关键词 ATTENTION computerIZED Neuro-physiological TEST FUZZY system
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COMPUTERIZED SIMULATION OF THERMODYNAMICS FOR MOLTEN LiF-KF SOLUTION BY MONTE CARLO METHOD
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作者 XU Chi JIANG Naixiong CHEN Nianyi Shanghai Institute of Metallurgy,Academia Sinica,Shanghai,China 《Acta Metallurgica Sinica(English Letters)》 SCIE EI CAS CSCD 1992年第8期145-148,共4页
The structure and behaviour of LiF-KF solution,as a typical common-anion system,has been simulated by Monte Carlo method.The calculation of partial radial distribution function of ions,heat of mixing and potential ene... The structure and behaviour of LiF-KF solution,as a typical common-anion system,has been simulated by Monte Carlo method.The calculation of partial radial distribution function of ions,heat of mixing and potential energy distribution shows that the average distance be- tween Li^+ and F^- ions will significantly narrow after mixing of molten LiF and KF.This is very similar to the lean-on-one-side effect in molten LiF-KCl solution.The calculated heat of mixing is in fair agreement with the measured one.The dominant source of the energy of mixing may be that the decrease of the repulsion energy between cations,the decrease of the attraction energy between cations and anions,and the decrease of the repulsion energy be- tween anions. 展开更多
关键词 molten salt Monte Carlo method computerized simulation thermodynamic property LiF-KF system
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CT动态容积扫描与增强扫描对泌尿系病变患者的诊断价值对比
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作者 赵御森 朱晓龙 +5 位作者 王耀一 周义 张志敏 胡振顺 朱月香 许园博 《长春中医药大学学报》 2023年第6期683-686,共4页
目的 对比计算机断层扫描(CT)动态容积扫描与增强扫描对泌尿系病变患者的诊断价值。方法 回顾性收集2020年1月-2021年12月我院收治的200例疑似泌尿系病变患者临床资料,患者均经病理检查确诊,根据检查方法分为A组与B组,各100例,2组均进... 目的 对比计算机断层扫描(CT)动态容积扫描与增强扫描对泌尿系病变患者的诊断价值。方法 回顾性收集2020年1月-2021年12月我院收治的200例疑似泌尿系病变患者临床资料,患者均经病理检查确诊,根据检查方法分为A组与B组,各100例,2组均进行CT检查,其中A组采用常规CT平扫联合增强扫描进行检查,B组采用常规CT平扫联合动态容积扫描进行检查。比较2组CT值、噪声、图像质量主观评分及辐射剂量、疾病诊断准确率。结果 A组肾动脉、腹主动脉、腹腔干、肠系膜上动脉、输尿管CT值及图像质量主观评分低于B组(P <0.05),肾动脉、腹主动脉、腹腔干、肠系膜上动脉噪声、信噪比、对比噪声及CT剂量指数(CTDlvo1)、剂量长度乘积(DLP)、有效剂量(ED)高于B组(P <0.05)。B组诊断准确率(93.00%,93/100)显著高于A组(83.00%,83/100)(P <0.05)。结论 与常规CT平扫联合增强扫描相比,采用常规CT平扫联合动态容积扫描对泌尿系病变进行诊断,可有效提高检查CT值、图像质量及诊断准确率,降低噪声和辐射剂量,具有较好的应用效果。 展开更多
关键词 泌尿系病变 计算机断层扫描 增强扫描 动态容积 诊断
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Preliminary observation results of the Coherent Beacon Systemonboard the China Seismo-Electromagnetic Satellite-1 被引量:4
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作者 Liang Chen Ming Ou +3 位作者 YaPing Yuan Fang Sun Xiao Yu WeiMin Zhen 《Earth and Planetary Physics》 2018年第6期505-514,共10页
This paper reports, for the first time, observation results of the Coherent Beacon System(CBS) onboard the China SeismoElectromagnetic Satellite-1(CSES-1). We describe the CBS, and the Computerized Ionospheric Tomogra... This paper reports, for the first time, observation results of the Coherent Beacon System(CBS) onboard the China SeismoElectromagnetic Satellite-1(CSES-1). We describe the CBS, and the Computerized Ionospheric Tomography(CIT) algorithm program is validated by numerical experiment. Two examples are shown, for daytime and nighttime respectively. The Equatorial Ionization Anomaly(EIA) can be seen, and the northern crest core is located at ~20°N in the reconstruction image at 07:28 UTC on 20 July 2018(daytime).Disturbances are shown in the reconstruction image at 18:40 UTC on 13 July 2018(nighttime). We find that beacon measurements are more consistent with ionosonde measurements than model results, by comparing Nm F2 at three sites at Lanzhou, Chongqing, and Kunming; consistency with ionosonde measurements validates beacon measurements. Finally, we have studied Vertical Total Electron Content(VTEC) variations from ground to ~500 km(the height of CSES-1 orbit) and ratios of VTEC between beacon measurements and CODE(Center for Orbit Determination in Europe) data. VTEC variation from ground to ~500 km has a range of 7.2–16.5 TECU for the daytime case and a range of 1.1–1.7 TECU for the nighttime case. The Beacon/CODE ratio of VTEC varies with latitude and time. The mean Beacon/CODE ratio is 0.69 for the daytime case and 0.26 for the nighttime case. The fact that the nighttime case yields lower ratios indicates the higher altitude of the ionosphere during nighttime when the ionosphere is assumed to be a thin layer. 展开更多
关键词 Coherent Beacon system(CBS) China Seismo-Electromagnetic Satellite-1(CSES-1) computerized Ionospheric Tomography(CIT) Total Electron Content(TEC)
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乳腺癌患者新发心血管疾病预测模型的建立与验证:基于内蒙古区域医疗数据
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作者 张云静 乔丽颖 +6 位作者 祁萌 严颖 亢伟伟 刘国臻 王明远 席云峰 王胜锋 《北京大学学报(医学版)》 CAS CSCD 北大核心 2023年第3期471-479,共9页
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... 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。 展开更多
关键词 乳腺肿瘤 心血管疾病 风险预测模型 危险性评估 计算机化病案系统
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新建药品仓库计算机化系统风险管理与验证
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作者 郑茜 黄海燕 严伟民 《上海医药》 CAS 2023年第9期58-62,共5页
《药品生产质量管理规范》附件10计算机化系统是药品生产企业所必需遵循的重要法规之一。本文以新建药品仓库计算机化系统中的管理系统为例,参考了ISPE,PICS及FDA对此类计算机化系统的要求,结合作者经验提出该系统基于风险管理的验证流程。
关键词 风险评估 风险控制 风险回顾 计算机化系统验证
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计算机化系统验收探讨
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作者 梁玉清 《无线互联科技》 2023年第23期152-155,共4页
计算机系统在高等院校教学和管理工作中的应用日益广泛,借助计算机化系统提高管理效率,成为各个高校管理部门的必要选择。为了确保计算机化系统运行稳定,就要提高计算机化系统验收的水平。文章通过对计算机化系统硬件、软件等进行风险评... 计算机系统在高等院校教学和管理工作中的应用日益广泛,借助计算机化系统提高管理效率,成为各个高校管理部门的必要选择。为了确保计算机化系统运行稳定,就要提高计算机化系统验收的水平。文章通过对计算机化系统硬件、软件等进行风险评估,确定硬件和软件的验收方式;根据验收风险的评估结果,选择合适的检验方式。进行系统化、规范化计算机化系统的验收,对于确保计算机化系统运行的有效性和稳定性有着极其重要的作用。 展开更多
关键词 计算机化系统 验收 风险评估
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