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A Score Type Test for General Autoregressive Models in Time Series 被引量:3
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作者 Jian-hong Wu Li-xing Zhu 《Acta Mathematicae Applicatae Sinica》 SCIE CSCD 2007年第3期439-450,共12页
This paper is devoted to the goodness-of-fit test for the general autoregressive models in time series. By averaging for the weighted residuals, we construct a score type test which is asymptotically standard chi-squa... This paper is devoted to the goodness-of-fit test for the general autoregressive models in time series. By averaging for the weighted residuals, we construct a score type test which is asymptotically standard chi-squared under the null and has some desirable power properties under the alternatives. Specifically, the test is sensitive to alternatives and can detect the alternatives approaching, along a direction, the null at a rate that is arbitrarily close to n-1/2. Furthermore, when the alternatives are not directional, we construct asymptotically distribution-free maximin tests for a large class of alternatives. The performance of the tests is evaluated through simulation studies. 展开更多
关键词 Autoregressive model GOODNESS-OF-FIT maximin test model checking score type test time series
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TESTING THE ADEQUACY OF GARCH-TYPE MODELS IN TIME SERIES 被引量:1
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作者 吴鑑洪 朱力行 《Acta Mathematica Scientia》 SCIE CSCD 2009年第2期327-340,共14页
In this article a new approach for checking the adequacy of GARCH-type models in time series was proposed. The resulted tests involve weight functions, which provide them with the flexibility in choosing scores to enh... In this article a new approach for checking the adequacy of GARCH-type models in time series was proposed. The resulted tests involve weight functions, which provide them with the flexibility in choosing scores to enhance power performance. The choice of weight functions and the power properties of the tests are studied. For a large number of alternatives, asymptotically distribution-free maximin test is constructed. The tests are asymptotically chi-squared under the null hypothesis and easy to implement. Simulation results indicate that the tests perform well. 展开更多
关键词 GARCH-type models maximin test model diagnostic checking score type test
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PERCENTAGE POINTS AND POWER OF AK-S TYPE TEST FOR LINEARITY IN AUTOREGRESSIVE TIME SERIES
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作者 陈敏 吴国富 《Acta Mathematicae Applicatae Sinica》 SCIE CSCD 2001年第4期433-442,共10页
The empirical upper percentage points of the null distribution of a Kolmogorov-Smirnov type test for checking linearity in autoregressive models are tabulated in this paper, and the good power property of the test is ... The empirical upper percentage points of the null distribution of a Kolmogorov-Smirnov type test for checking linearity in autoregressive models are tabulated in this paper, and the good power property of the test is demonstrated. 展开更多
关键词 Kolmogorov-Smirnov type test LINEARITY empirical upper percentage points Monte Carlo simulations
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Genetic test in multiple endocrine neoplasia type 1 syndrome: An evolving story 被引量:2
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作者 Francesca Marini Francesca Giusti Maria Luisa Brandi 《World Journal of Experimental Medicine》 2015年第2期124-129,共6页
Multiple endocrine neoplasia type 1(MEN1) is an autosomal dominant inherited tumour syndrome expressing various endocrine and non-endocrine lesions and tumours. Since the identification of the causative gene, the onco... Multiple endocrine neoplasia type 1(MEN1) is an autosomal dominant inherited tumour syndrome expressing various endocrine and non-endocrine lesions and tumours. Since the identification of the causative gene, the oncosuppressor gene MEN1, in 1997, genetic testing has revealed an important approach for the early and differential diagnosis of the disease. The finding of a MEN1 mutation in a patient has important clinical implications for relatives since it allows very early disease diagnosis and identification of carriers, even before biochemical and/or clinical manifestation, permitting their inclusion in a specific program of surveillance and subsequent praecox therapy. Currently, genetic testing for MEN1 consists principally of the sequencing of coding regions and intron-exon junctions of the MEN1 gene. However, the recent acquisition of novel high throughput technologies will allow the design of innovative, accurate, complete and rapid genetic diagnosis. These new tools are able to increase the strength of the analysis and almost completely eliminate the possibility of false negative results. This review aims to give an overview on genetic testing of MEN1 syndrome, reporting the positive aspects of performing the analysis and the future perspectives for improving the performance of the test, as well as its application in clinical practice. 展开更多
关键词 Multiple ENDOCRINE NEOPLASIA type 1 Genetic test Clinical practice Next-generation SEQUENCING
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Evaluation and diagnostic testing of erectile dysfunction in the era of phosphodiesterase type 5 inhibitors 被引量:1
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作者 Kenneth Jacobsohn Run Wang 《Asian Journal of Andrology》 SCIE CAS CSCD 2007年第1期3-7,共5页
The diagnosis and treatment of erectile dysfunction has changed dramatically since the availability of safe and effective oral therapies. Unfortunately, not all men can be adequately treated in this way, and might req... The diagnosis and treatment of erectile dysfunction has changed dramatically since the availability of safe and effective oral therapies. Unfortunately, not all men can be adequately treated in this way, and might require more invasive testing to diagnose and treat the specific cause of their dysfunction. This review looks at the tests and strategies available for men who cannot be treated by oral therapy alone. 展开更多
关键词 erectile dysfunction testING TREATMENT DIAGNOSIS phosphodiesterase type 5 inhibitors
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An Immunochromatographic Strip Test for Rapid Detection of Antibodies against Porcine Circovirus Type 2
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作者 ZHANG Wen-tong WEI Feng +2 位作者 WANG Jin-liang XIAO Yue-qiang SHEN Zhi-qiang 《Animal Husbandry and Feed Science》 CAS 2011年第5期26-29,共4页
Porcine cimovirus type 2 (PCV2) infection causes huge economic losses, but no serological method is available for batch detection of field samples. The aim of the study was to develop a method for large-batch detectio... Porcine cimovirus type 2 (PCV2) infection causes huge economic losses, but no serological method is available for batch detection of field samples. The aim of the study was to develop a method for large-batch detection of PCV2 infection. Colloidal gold-labeled staphylococcal protein A (SPA) was sprayed on glass fibers to prepare a conjugate pad. The recombinant ORF2 protein of PCV2 was blotted on the test line of the nitrocellulose (NC) membrane, and pig IgG was streaked on the control line of the NC membrane. Then, the immunochromatographic strip was used for detection of antibodies against PCV2. The results show that the strip test was simple and the results could be determined within 10 min with naked eyes. The test strip was highly specific for pig serum against PCV2 and no cross-reaction with pig serum against other pathogens was observed. The test strip had close similarity with ELISA. Storage at RT for 6 months did not affect the specificity and sensitivity obviously. A total of 324 clinical pig sera were detected by both ELISA and the developed test strip, and the coincidence was 98.77%. Therefore, the developed immunochromatographic strip is specific, sensitive, stable, fast and simple, and it is suitable for on-site detection of antibodies against PCV2. 展开更多
关键词 Porcine circovirus type 2 IMMUNOCHROMATOGRAPHY test strip
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Response of low active GLP-1 like substances to test meal in obese Japanese patients with type 2 diabetes mellitus compared with obese controls with normal glucose tolerance
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作者 Kyuzi Kamoi Nobumasa Ohara +3 位作者 Tomoo Ikarashi You Shinozaki Kazuo Furukawa Hideo Sasaki 《Journal of Diabetes Mellitus》 2012年第3期265-271,共7页
Background: A secretion of plasma active GLP-1 (p-active GLP-1) after ingestion of breakfast test meal (TM) is decreased in obese European patients with type 2 diabetes mellitus (T2DM). However, there was no significa... Background: A secretion of plasma active GLP-1 (p-active GLP-1) after ingestion of breakfast test meal (TM) is decreased in obese European patients with type 2 diabetes mellitus (T2DM). However, there was no significant difference in pactive GLP-1 secretion following TM between obese Japanese patients with T2DM and controls. The findings indicate the difference may be due to different races or dietary’s customs of subjects. Aims: We examined whether pactive GLP-1 is truly affected by TM in obese Japanese patients (n = 24, group 1) and obese controls (n = 12, group 2). Methods: Glucose (PG), insulin (s-IRI), C-peptide (s-CPR) and active GLP-1 like substances (p-active GLP-1-S) levels in blood were measured 0, 30 and 60 min after TM. Obese Japanese patients with mean 9 years of diabetes had micro- and macro-vascular disturbances and were treated with diet, exercise and/or oral drugs for hyperglycemia. Results: There was no significant difference in sex, age or BMI between groups. Means HbA1c and PG were significantly higher in group 1 than in group 2. There were no significant differences in means of basal s-IRI, HOMA-R and s-CPR between groups. However, means of HOMA-β, insulinogenic index, postprandial s-IRI, s-CPR and p-active GLP-1-S or p-active GLP-1-S/PG values after TM were significantly lower in group 1 than in group 2. Conclusions: These results indicate that a response of p-active GLP-1-S after TM in obese Japanese patients with T2DM was decreased and secretion of GLP-1 relative to PG was impaired. The method of enhancing function of active GLP-1 may be useful for treatment in some of patients with diabetes mellitus. 展开更多
关键词 ACTIVE GLP-1 test MEAL BMI Obesity JAPANESE type 2DM
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On the Distribution of Type II Errors in Hypothesis Testing
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作者 Skip Thompson 《Applied Mathematics》 2011年第2期189-195,共7页
When a statistical test of hypothesis for a population mean is performed, we are faced with the possibility of committing a Type II error by not rejecting the null hypothesis when in fact the population mean has chang... When a statistical test of hypothesis for a population mean is performed, we are faced with the possibility of committing a Type II error by not rejecting the null hypothesis when in fact the population mean has changed. We consider this issue and quantify matters in a manner that differs a bit from what is commonly done. In particular, we define the probability distribution function for Type II errors. We then explore some interesting properties that we have not seen mentioned elsewhere for this probability distribution function. Finally, we discuss several Maple procedures that can be used to perform various calculations using the distribution. 展开更多
关键词 COMPLEMENTARY ERROR Function HYPOTHESIS testing POWER CURVES POWER Surfaces type II ERRORS
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Inference for constant-stress accelerated life test with Type-I progressively hybrid censored data from Burr-XII distribution
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作者 Jiao Zhao Yimin Shi Weian Yan 《Journal of Systems Engineering and Electronics》 SCIE EI CSCD 2014年第2期340-348,共9页
This paper proposes a simple constant-stress accel- erated life test (ALT) model from Burr type XII distribution when the data are Type-I progressively hybrid censored. The maximum likelihood estimation (MLE) of t... This paper proposes a simple constant-stress accel- erated life test (ALT) model from Burr type XII distribution when the data are Type-I progressively hybrid censored. The maximum likelihood estimation (MLE) of the parameters is obtained through the numerical method for solving the likelihood equations. Approxi- mate confidence interval (CI), based on normal approximation to the asymptotic distribution of MLE and percentile bootstrap Cl is derived. Finally, a numerical example is introduced and then a Monte Carlo simulation study is carried out to illustrate the pro- posed method. 展开更多
关键词 constant-stress accelerated life test (ALT) Burr type-Xll distribution type-I progressively hybrid censoring maximumlikelihood estimation (MLE) confidence interval (CI).
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Comparison of Type I Error Rates of Siegel-Tukey and Savage Tests among Non-Parametric Tests
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作者 Sahib Ramazanov Hakan Çora 《Open Journal of Applied Sciences》 2024年第9期2393-2410,共18页
This study aimed to examine the performance of the Siegel-Tukey and Savage tests on data sets with heterogeneous variances. The analysis, considering Normal, Platykurtic, and Skewed distributions and a standard deviat... This study aimed to examine the performance of the Siegel-Tukey and Savage tests on data sets with heterogeneous variances. The analysis, considering Normal, Platykurtic, and Skewed distributions and a standard deviation ratio of 1, was conducted for both small and large sample sizes. For small sample sizes, two main categories were established: equal and different sample sizes. Analyses were performed using Monte Carlo simulations with 20,000 repetitions for each scenario, and the simulations were evaluated using SAS software. For small sample sizes, the I. type error rate of the Siegel-Tukey test generally ranged from 0.045 to 0.055, while the I. type error rate of the Savage test was observed to range from 0.016 to 0.041. Similar trends were observed for Platykurtic and Skewed distributions. In scenarios with different sample sizes, the Savage test generally exhibited lower I. type error rates. For large sample sizes, two main categories were established: equal and different sample sizes. For large sample sizes, the I. type error rate of the Siegel-Tukey test ranged from 0.047 to 0.052, while the I. type error rate of the Savage test ranged from 0.043 to 0.051. In cases of equal sample sizes, both tests generally had lower error rates, with the Savage test providing more consistent results for large sample sizes. In conclusion, it was determined that the Savage test provides lower I. type error rates for small sample sizes and that both tests have similar error rates for large sample sizes. These findings suggest that the Savage test could be a more reliable option when analyzing variance differences. 展开更多
关键词 Non-Parametric test Siegel-Tukey test Savage test Monte Carlo Simulation type I Error
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基于Type-CCC通道PD协议合规测试的失败诊断与整改研究
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作者 周宁 盘建国 +1 位作者 赵奎 莫贤标 《日用电器》 2025年第11期80-84,共5页
随着欧盟通用充电器指令推动Type-C接口与PD协议的强制实施,便携设备在PD合规测试中面临诸多兼容性挑战。本文针对Type-CCC通道PD协议测试中常见的失败类型,如配置偏差、信号完整性不足、协议响应异常、低功耗管理不善及死电池场景处理... 随着欧盟通用充电器指令推动Type-C接口与PD协议的强制实施,便携设备在PD合规测试中面临诸多兼容性挑战。本文针对Type-CCC通道PD协议测试中常见的失败类型,如配置偏差、信号完整性不足、协议响应异常、低功耗管理不善及死电池场景处理不当等常见问题,开展系统性的诊断与整改研究。通过分层优化策略,包括VIF参数调整、硬件电路改进和固件逻辑增强,重点对SinkDeadBatteryTest进行实验验证。结果表明,整改后设备通过率显著提升,各类关键指标均得到明显改善,有效增强了设备互操作性与合规性,为后续多协议兼容与高功率场景优化提供了实践基础。 展开更多
关键词 type-CCC通道 PD协议 合规测试 失败诊断
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静脉注射重组Ⅲ型人源化胶原蛋白的一般毒理学研究
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作者 刘欢 陈建华 +5 位作者 尹晶晶 李建华 张天睿 王若琪 高洁 李建国 《癌变·畸变·突变》 2026年第1期59-63,78,共6页
目的:评价重组Ⅲ型人源化胶原蛋白的安全性,为其临床安全使用的剂量设计和临床毒副反应监测提供参考资料。方法:急性毒性试验采用最大耐受量法,3~5周龄ICR小鼠以最大给药剂量2 000 mg/kg尾静脉注射单次给药,观察大鼠的毒性反应情况。长... 目的:评价重组Ⅲ型人源化胶原蛋白的安全性,为其临床安全使用的剂量设计和临床毒副反应监测提供参考资料。方法:急性毒性试验采用最大耐受量法,3~5周龄ICR小鼠以最大给药剂量2 000 mg/kg尾静脉注射单次给药,观察大鼠的毒性反应情况。长期毒性试验选用6周龄SD大鼠120只,分为130、65、32.5 mg/kg剂量组和对照组,每组30只大鼠,连续给药28天,恢复28天,主要检查指标包括大鼠眼科、体质量、饲料消耗量、血液学指标、血清生化、血凝指标、尿液指标和组织病理学等的变化。结果:急性毒性试验中,小鼠尾静脉注射重组Ⅲ型人源化胶原蛋白最大耐受剂量大于2 000 mg/kg,相当于临床拟用剂量的1 503.76倍,且未见明显的毒副反应。28天重复给药毒性试验中,SD大鼠尾静脉注射重组Ⅲ型人源化胶原蛋白基本无毒反应剂量为130 mg/kg,相当于成人拟用剂量的97.74倍。结论:在本试验条件下,重组Ⅲ型人源化胶原蛋白未见明显毒性反应。 展开更多
关键词 重组Ⅲ型人源化胶原蛋白 急性毒性 长期毒性 非临床安全性评价
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Kolmogorov-Smirnov APF Test for Inhomogeneous Poisson Processes with Shift Parameter 被引量:1
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作者 E. D. Wandji Tanguep D. A. Njamen Njomen 《Applied Mathematics》 2021年第4期322-335,共14页
In this article, we study the Kolmogorov-Smirnov type goodness-of-fit test for the inhomogeneous Poisson process with the unknown translation parameter as multidimensional parameter. The basic hypothesis and the alter... In this article, we study the Kolmogorov-Smirnov type goodness-of-fit test for the inhomogeneous Poisson process with the unknown translation parameter as multidimensional parameter. The basic hypothesis and the alternative are composite and carry to the intensity measure of inhomogeneous Poisson process and the intensity function is regular. For this model of shift parameter, we propose test which is asymptotically partially distribution free and consistent. We show that under null hypothesis the limit distribution of this statistic does not depend on unknown parameter. 展开更多
关键词 Inhomogeneous Poisson Process Kolmogorov-Smirnov type test Parametric Basic Hypothesis Asymptotic Parameter Free test Shift Parameter
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Wipe Test在HLA组织配型实验室污染监测及预防管理中的应用 被引量:1
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作者 武君华 尚利侠 +5 位作者 陈乐 王小芳 王天菊 王满妮 房婕 齐珺 《检验医学与临床》 CAS 2020年第3期358-362,共5页
目的建立人类白细胞抗原(HLA)组织配型实验室常规DNA污染监测试验体系,预防和消除可能会干扰检测准确性的PCR产物或基因组DNA的污染。方法设计含多种阴阳性对照和各关键监测点的完整反应链,针对HLA-Ⅰ类和Ⅱ类基因扩增区域内的非多态区... 目的建立人类白细胞抗原(HLA)组织配型实验室常规DNA污染监测试验体系,预防和消除可能会干扰检测准确性的PCR产物或基因组DNA的污染。方法设计含多种阴阳性对照和各关键监测点的完整反应链,针对HLA-Ⅰ类和Ⅱ类基因扩增区域内的非多态区进行引物特异性PCR,琼脂糖凝胶电泳测定扩增产物;对被污染监测点进行局部灭活处理后对相应监测点重新采样进行灭活验证;同时采取不定期抽查监测与定期全面监测相结合的方式确保实验过程零污染。结果灭活处理及整改后,所监测HLA基因分型实验过程中的核酸抽提区、PCR加样区、PCR扩增区、下游产物处理区4个区域的主要监测点污染监测结果均合格。结论该研究建立的以Wipe Test为核心的DNA防污染监测实验体系能够有效监测和灭活验证可能会干扰检测准确性的PCR产物或基因组DNA的污染,是HLA组织配型实验室质量控制管理程序的重要组成部分。 展开更多
关键词 HLA组织配型实验室 擦拭试验 污染监测
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预切种式横向甘蔗种植机供种系统的设计与试验
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作者 麻芳兰 陈京盛 +3 位作者 叶凤滋 樊广坤 陈彬 滕筱 《农机化研究》 北大核心 2026年第4期241-248,共8页
为了解决当前预切种式甘蔗横向种植机供种装置工作时所需人工多、劳动强度大、过程复杂和持续供种量不足的问题,设计了一套具有持续性并且能够实现有序供种的供种系统,并通过分析蔗种在供种系统工作过程中的运动机理找出影响供种效率和... 为了解决当前预切种式甘蔗横向种植机供种装置工作时所需人工多、劳动强度大、过程复杂和持续供种量不足的问题,设计了一套具有持续性并且能够实现有序供种的供种系统,并通过分析蔗种在供种系统工作过程中的运动机理找出影响供种效率和合格率的关键参数。在SolidWorks中对供种系统进行三维建模,运用Adams软件对简化后的供种系统进行了虚拟仿真单因素试验,验证了供种系统的功能性。结果表明:车厢导流板倾角越大,供种合格率越低;供种链速越快,供种效率越高、合格率越低;集蔗箱导蔗板倾角越大,供种合格率越低。自主搭建了供种系统车间试验平台并进行了正交试验,探究了车厢导流板倾角、供种链速和集蔗箱导蔗板倾角对供种合格率的影响。试验发现:导流板倾角、供种链速和导蔗板倾角对供种合格率均具有显著影响,供种合格率最优参数组合为供种链速0.22 m/s、集蔗箱导蔗板倾角40°、车厢导流板倾角20°。 展开更多
关键词 甘蔗横向种植机 供种系统 预切种式 三维建模 虚拟仿真 正交试验
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一种电子束熔炼设备波纹管结构优化设计研究
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作者 闫超 贾子朝 《真空》 2026年第1期88-96,共9页
蒸发器装置作为电子束熔炼的核心设备,其冷却水路关键位置依靠波纹管进行连接,在使用过程中波纹管存在弯曲失效现象。本文针对现有蒸发装置所用波纹管A开展失效分析,依据设计指标针对波纹管结构进行优化设计,完成波纹管耐压强度、疲劳... 蒸发器装置作为电子束熔炼的核心设备,其冷却水路关键位置依靠波纹管进行连接,在使用过程中波纹管存在弯曲失效现象。本文针对现有蒸发装置所用波纹管A开展失效分析,依据设计指标针对波纹管结构进行优化设计,完成波纹管耐压强度、疲劳寿命、刚度、稳定性的设计计算。并建立有限元数值仿真模型,对波纹管开展应力、变形量、内流阻的数值计算,最终确定了波纹管B、C两类优化结构。同时开展波纹管B、C实物的型式检验,验证波纹管密封、耐压、刚度、稳定性、疲劳性能。最终结果表明,结构优化的波纹管B、C均满足设计要求,整体性能指标良好。 展开更多
关键词 波纹管 结构优化 有限元仿真 型式试验
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矿用单体液压支柱型式试验装置液压系统设计
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作者 吴波 高洋 +2 位作者 张一鸣 陈翀 曹泽仁 《煤矿机械》 2026年第1期21-25,共5页
矿用单体液压支柱是煤矿井下工作面顶板支护的核心装备。长期以来,国内对MT/T112.1—2006行业标准所规定的型式试验装置研究较为薄弱,特别是在操作性能、让压性能、密封性能、耐久性能及强度等关键型式试验项目的液压系统设计方面存在... 矿用单体液压支柱是煤矿井下工作面顶板支护的核心装备。长期以来,国内对MT/T112.1—2006行业标准所规定的型式试验装置研究较为薄弱,特别是在操作性能、让压性能、密封性能、耐久性能及强度等关键型式试验项目的液压系统设计方面存在技术难点。在分析矿用单体液压支柱现状与发展趋势的基础上,依据标准型式试验要求,开展了液压原理设计、元件选型与系统仿真分析,构建了满足试验要求的液压系统。通过油液与乳化液双系统联动设计及关键元件的优化选型,有效解决了单体液压支柱试验系统稳定性问题,达到了标准与装备功能要求。试验结果表明,该系统性能稳定、运行可靠,可全面满足标准对型式检验项目的各项要求。 展开更多
关键词 矿用单体液压支柱 型式试验 试验装置 液压系统
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TypeⅡ试验下ε(λ,μ)分布位置参数的EB估计
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作者 叶尔骅 杨纪龙 《南京航空航天大学学报》 CAS CSCD 1995年第3期333-340,共8页
讨论了在TypeⅡ(无替换定数截尾)试验方案下,当产品寿命为双参数指数分布时,位置参数μ的经验Bayes(简记EB)估计及其收敛速度问题。设受试产品有n个,试验中前r个产品依次出现的失效时间为t(1)≤t(2)≤…≤... 讨论了在TypeⅡ(无替换定数截尾)试验方案下,当产品寿命为双参数指数分布时,位置参数μ的经验Bayes(简记EB)估计及其收敛速度问题。设受试产品有n个,试验中前r个产品依次出现的失效时间为t(1)≤t(2)≤…≤t(r),令记:μ的Bayes点估计为(x,y),利用密度函数及其偏导数的核估计构造出μ的EB估计为(x,y),(x,y)与(x,y)的Bayes风险分别为R_(2x)与R_(2m)。在一定的正则条件下,证明了这表明,μ的EB估计的收敛速度q可任意接近于1/4。 展开更多
关键词 统计分析 可靠性 指数分布 收敛速度
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基于需求和源代码分析的软件回归测试技术
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作者 代晓倩 丁翠玲 高赛军 《工业控制计算机》 2026年第1期45-46,共2页
从软件更改目的出发对软件更改类型进行了划分,并基于更改类型分析阐述了基于需求和源代码分析的更改确认方法,强调了基于需求和源代码分析开展更改确认的意义,增强了更改确认分析的充分性和有效性。从工程应用角度对基于源代码的更改... 从软件更改目的出发对软件更改类型进行了划分,并基于更改类型分析阐述了基于需求和源代码分析的更改确认方法,强调了基于需求和源代码分析开展更改确认的意义,增强了更改确认分析的充分性和有效性。从工程应用角度对基于源代码的更改影响域分析技术进行了分析和总结,阐述了一种基于更动模块和全局资源分析的方法,有效地保证了回归测试的充分性。 展开更多
关键词 回归测试 更改类型 需求更改 影响域分析 源代码
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定量检测试剂中具有可比性的样本类型适用性评价概述
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作者 吴昊楠 熊宇婷 《分子诊断与治疗杂志》 2026年第1期222-224,共3页
对包含具有可比性的样本类型的定量检测试剂在注册申报中,需要样本适用性评价,方式可以参考实验室样本检测评价,主要包括可比性验证、测量程序内比对和干扰试验。本文结合体外诊断试剂注册申报要求及注册审查指导原则,系统阐述了具有可... 对包含具有可比性的样本类型的定量检测试剂在注册申报中,需要样本适用性评价,方式可以参考实验室样本检测评价,主要包括可比性验证、测量程序内比对和干扰试验。本文结合体外诊断试剂注册申报要求及注册审查指导原则,系统阐述了具有可比性的样本类型的内容及国内外技术文件的评价方式,旨在为定量检测试剂的性能评价和注册申报提供参考。 展开更多
关键词 样本类型 适用性 可比性 测量程序比对 干扰试验
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