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大锻件统计学Chi-square test的研究和应用 被引量:3
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作者 齐作玉 吕亚臣 任运来 《大型铸锻件》 2011年第1期9-11,25,共4页
根据大锻件生产的特点和统计学的基本理论方法,首次深入浅出地论述了大锻件的Chi-square test,即X2检验,并给出了具体应用示例。该方法可用于大锻件工艺参数的科学分析和生产验证,可用于大锻件质量分析和判断,可帮助逐步建立起大锻件的... 根据大锻件生产的特点和统计学的基本理论方法,首次深入浅出地论述了大锻件的Chi-square test,即X2检验,并给出了具体应用示例。该方法可用于大锻件工艺参数的科学分析和生产验证,可用于大锻件质量分析和判断,可帮助逐步建立起大锻件的工序能力,帮助实现稳定并提升大锻件工艺和质量控制水平。 展开更多
关键词 大锻件 chi-square test 统计学
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Optimization Method of Suspected Electricity Theft Topic Model Based on Chi-square Test and Logistic Regression 被引量:1
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作者 Jian Dou Ye Aliaosha 《国际计算机前沿大会会议论文集》 2018年第2期32-32,共1页
关键词 Anti-electricity THEFT chi-square test LOGISTIC regressionPower consumption inspection
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Large Deviations and Moderate Deviations for the Chi-Square Test in Type Ⅱ Error
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作者 JIANG Hui GAO Fuqing 《Wuhan University Journal of Natural Sciences》 CAS 2008年第2期129-132,共4页
We study the asymptotics tot the statistic of chi-square in type Ⅱ error. By the contraction principle, the large deviations and moderate deviations are obtained, and the rate function of moderate deviations can be c... We study the asymptotics tot the statistic of chi-square in type Ⅱ error. By the contraction principle, the large deviations and moderate deviations are obtained, and the rate function of moderate deviations can be calculated explicitly which is a squared function. 展开更多
关键词 large deviations moderate deviations chi-square test
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Data Consistency Tests through the Use of Neural Networks and Virial Equation. Application of the Proposed Methodology to Critical Study of Density Data
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作者 Abdeslam Hassen Meniai Serge Laugier +1 位作者 Hakim Madani Dominique Richon 《Open Journal of Physical Chemistry》 2011年第3期61-69,共9页
This paper focuses on a very important point which consists in evaluating experimental data prior to their use for chemical process designs. Hexafluoropropylene P, ρ, T data measured at 11 temperatures from 263 to 36... This paper focuses on a very important point which consists in evaluating experimental data prior to their use for chemical process designs. Hexafluoropropylene P, ρ, T data measured at 11 temperatures from 263 to 362 K and at pressures up to 10 MPa have been examined through a consistency test presented herein and based on the use of a methodology implying both neural networks and Virial equation. Such a methodology appears as very powerful to identify erroneous data and could be conveniently handled for quick checks of databases previously to modeling through classical thermodynamic models and equations of state. As an application to liquid and vapor phase densities of hexafluoropropylene, a more reliable database is provided after removing out layer data. 展开更多
关键词 consistENCY tests HEXAFLUOROPROPYLENE NEURAL Networks Vibrating Tube DENSIMETER VIRIAL Equation
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Use of Pearson’s Chi-Square for Testing Equality of Percentile Profiles across Multiple Populations
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作者 William D. Johnson Robbie A. Beyl +3 位作者 Jeffrey H. Burton Callie M. Johnson Jacob E. Romer Lei Zhang 《Open Journal of Statistics》 2015年第5期412-420,共9页
In large sample studies where distributions may be skewed and not readily transformed to symmetry, it may be of greater interest to compare different distributions in terms of percentiles rather than means. For exampl... In large sample studies where distributions may be skewed and not readily transformed to symmetry, it may be of greater interest to compare different distributions in terms of percentiles rather than means. For example, it may be more informative to compare two or more populations with respect to their within population distributions by testing the hypothesis that their corresponding respective 10th, 50th, and 90th percentiles are equal. As a generalization of the median test, the proposed test statistic is asymptotically distributed as Chi-square with degrees of freedom dependent upon the number of percentiles tested and constraints of the null hypothesis. Results from simulation studies are used to validate the nominal 0.05 significance level under the null hypothesis, and asymptotic power properties that are suitable for testing equality of percentile profiles against selected profile discrepancies for a variety of underlying distributions. A pragmatic example is provided to illustrate the comparison of the percentile profiles for four body mass index distributions. 展开更多
关键词 Asymptotic chi-square test EQUALITY of PERCENTILES Large Sample test MEDIAN test NONPARAMETRIC Methods
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A Simple Chi-Square Statistic for Testing Homogeneity of Zero-Inflated Distributions
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作者 William D. Johnson Jeffrey H. Burton +1 位作者 Robbie A. Beyl Jacob E. Romer 《Open Journal of Statistics》 2015年第6期483-493,共11页
Zero-inflated distributions are common in statistical problems where there is interest in testing homogeneity of two or more independent groups. Often, the underlying distribution that has an inflated number of zero-v... Zero-inflated distributions are common in statistical problems where there is interest in testing homogeneity of two or more independent groups. Often, the underlying distribution that has an inflated number of zero-valued observations is asymmetric, and its functional form may not be known or easily characterized. In this case, comparisons of the groups in terms of their respective percentiles may be appropriate as these estimates are nonparametric and more robust to outliers and other irregularities. The median test is often used to compare distributions with similar but asymmetric shapes but may be uninformative when there are excess zeros or dissimilar shapes. For zero-inflated distributions, it is useful to compare the distributions with respect to their proportion of zeros, coupled with the comparison of percentile profiles for the observed non-zero values. A simple chi-square test for simultaneous testing of these two components is proposed, applicable to both continuous and discrete data. Results of simulation studies are reported to summarize empirical power under several scenarios. We give recommendations for the minimum sample size which is necessary to achieve suitable test performance in specific examples. 展开更多
关键词 Asymptotic chi-square test EQUALITY of QUANTILES Large Sample test Nonparametric test Percentile Profiles ZERO-INFLATED DISTRIBUTIONS
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Consistency check of degradation mechanism between natural storage and enhancement test for missile servo system 被引量:4
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作者 Wang Xu Sun Quan 《Journal of Systems Engineering and Electronics》 SCIE EI CSCD 2019年第2期415-424,共10页
Reliability enhancement testing(RET) is an accelerated testing which hastens the performance degradation process to surface its inherent defects of design and manufacture. It is an important hypothesis that the degrad... Reliability enhancement testing(RET) is an accelerated testing which hastens the performance degradation process to surface its inherent defects of design and manufacture. It is an important hypothesis that the degradation mechanism of the RET is the same as the one of the normal stress condition. In order to check the consistency of two mechanisms, we conduct two enhancement tests with a missile servo system as an object of the study, and preprocess two sets of test data to establish the accelerated degradation models regarding the temperature change rate that is assumed to be the main applied stress of the servo system during the natural storage. Based on the accelerated degradation models and natural storage profile of the servo system, we provide and demonstrate a procedure to check the consistency of two mechanisms by checking the correlation and difference of two sets of degradation data. The results indicate that the two degradation mechanisms are significantly consistent with each other. 展开更多
关键词 reliability ENHANCEMENT testing (RET) degradation model ACCELERATED equation consistENCY CHECK Pearson correlation coefficient
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Thermodynamic Consistency Test for Binary Gas + Water Equilibrium Data at Low and High Pressures 被引量:2
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作者 Claudio A. Fadndez Felipe A. Quiero Jose O. Valderrama 《Chinese Journal of Chemical Engineering》 SCIE EI CAS CSCD 2013年第10期1172-1181,共10页
Phase equilibrium in binary gas + water mixtures over wide ranges of temperatures and pressures are modeled and tested for thermodynamic consistency. For modeling, the Peng-Robinson equation of state was used and the ... Phase equilibrium in binary gas + water mixtures over wide ranges of temperatures and pressures are modeled and tested for thermodynamic consistency. For modeling, the Peng-Robinson equation of state was used and the Wong-Sandler mixing rules were incorporated into the equation of state parameters. In the Wong-Sandler mixing rules the van Laar model for the excess Gibbs energy was applied. In addition, a reasonable and flexible method is applied to test the thermodynamic consistency of pressure-temperature-concentration(P-T-x) data of these binary mixtures.Modeling is found acceptable in all cases, meaning that deviations in correlating the pressure and the gas phase concentration are low. For all cases the thermodynamic consistency method gives a clear conclusion about consistency or inconsistency of a set of experimental P-T-x data. 展开更多
关键词 vapor-liquid equilibrium gas-water systems Wong-Sandler mixing rule thermody-namic consistency test
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Chi-Square Distribution: New Derivations and Environmental Application
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作者 Thomas M. Semkow Nicole Freeman +8 位作者 Umme-Farzana Syed Douglas K. Haines Abdul Bari Abdul J. Khan Kimi Nishikawa Adil Khan Adam G. Burn Xin Li Liang T. Chu 《Journal of Applied Mathematics and Physics》 2019年第8期1786-1799,共14页
We describe two new derivations of the chi-square distribution. The first derivation uses the induction method, which requires only a single integral to calculate. The second derivation uses the Laplace transform and ... We describe two new derivations of the chi-square distribution. The first derivation uses the induction method, which requires only a single integral to calculate. The second derivation uses the Laplace transform and requires minimum assumptions. The new derivations are compared with the established derivations, such as by convolution, moment generating function, and Bayesian inference. The chi-square testing has seen many applications to physics and other fields. We describe a unique version of the chi-square test where both the variance and location are tested, which is then applied to environmental data. The chi-square test is used to make a judgment whether a laboratory method is capable of detection of gross alpha and beta radioactivity in drinking water for regulatory monitoring to protect health of population. A case of a failure of the chi-square test and its amelioration are described. The chi-square test is compared to and supplemented by the t-test. 展开更多
关键词 Mathematical Induction LAPLACE Transform GAMMA Distribution chi-square test GROSS Alpha-Beta DRINKING Water
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On the Different Ways to Handle the Trend of Disease Risk in Genetic Association Tests
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作者 Tapati Basak 《Open Journal of Statistics》 2022年第4期521-531,共11页
Genetic association studies usually apply the simple chi-square (χ<sup>2</sup>)-test for testing association between a single-nucleotide polymorphism (SNP) and a particular phenotype, assuming the genotyp... Genetic association studies usually apply the simple chi-square (χ<sup>2</sup>)-test for testing association between a single-nucleotide polymorphism (SNP) and a particular phenotype, assuming the genotypes and phenotypes are independent. So, the conventional χ<sup>2</sup>-test does not consider the increased risk of an individual carrying the increasing number of disease responsible allele (a particular genotype). But, the association tests should be performed with the consideration of this disease risk according to the mode of inheritance (additive, dominant, recessive). Practical demonstration of the two possible methods for considering such order or trends in contingency tables of genetic association studies using SNP genotype data is the purpose of this paper. One method is by pooling the genotypes, and the other is scoring the individual genotypes, based on the disease risk according to the inheritance pattern. The results show that the p-values obtained from both the methods are similar for the dominant and recessive models. The other important features of the methods were also extracted using the SNP genotype data for different inheritance patterns. 展开更多
关键词 Association chi-square Trend test SNP GENOTYPE
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雷达装备批生产阶段检验试验应用与探讨
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作者 敬敏 许可 +1 位作者 叶波 陈学锋 《电子质量》 2026年第1期84-89,共6页
例行试验、环境验收试验和质量一致性检验在质量控制和产品验证中各自扮演着重要角色。梳理了国军标及相关文献中关于雷达装备例行试验、环境验收试验和质量一致性检验的具体要求,并总结了相关领域的实践经验,针对当前应用中存在的概念... 例行试验、环境验收试验和质量一致性检验在质量控制和产品验证中各自扮演着重要角色。梳理了国军标及相关文献中关于雷达装备例行试验、环境验收试验和质量一致性检验的具体要求,并总结了相关领域的实践经验,针对当前应用中存在的概念混淆、实施阶段不清等问题,进一步厘清了三者之间的区别与联系,并开展了应用分析。本研究有助于规范雷达装备批生产阶段的检验与试验工作,为相关标准的科学实施提供参考依据。 展开更多
关键词 例行试验 环境验收试验 质量一致性检验 雷达装备
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超声波测风仪对比观测试验与分析
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作者 沈玉亮 王泽华 +1 位作者 张昊 周先锋 《气象水文海洋仪器》 2026年第1期14-18,共5页
文章通过静态测试、外场试验对超声波测风仪测风性能进行系统科学的评估分析,为超声波测风仪在气象观测业务中应用的可行性提供决策支撑。根据静态测试验证超声波测风仪开展外场试验的可行性,同时利用数据完整性、相关性、一致性等方法... 文章通过静态测试、外场试验对超声波测风仪测风性能进行系统科学的评估分析,为超声波测风仪在气象观测业务中应用的可行性提供决策支撑。根据静态测试验证超声波测风仪开展外场试验的可行性,同时利用数据完整性、相关性、一致性等方法对比分析两种测风仪的测风性能。试验结果表明,超声波测风仪的数据完整性较差,两种测风仪风速具有较强相关性,相关系数均在0.89以上;两者风向一致性显著,且2 min风向一致性优于10 min风向一致性;在风速5 m/s以上时,2 min和10 min风速平均值的系统偏差<0.1 m/s,标准偏差<0.9 m/s,2 min和10 min风向平均值的系统偏差<5°,标准偏差约为40°,2 min和10 min风向风速平均值的系统偏差和标准偏差差别较小。测试结果验证了超声波测风仪测风性能的可靠性,两种风向风速平均值可作为气象要素参考值供相关部门使用。 展开更多
关键词 静态测试 外场试验 测风仪 完整性 相关性 一致性
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化妆品多维度一致性评估方法
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作者 顾宇翔 胡芳华 刘恕 《日用化学品科学》 2026年第1期52-57,共6页
介绍了现有化妆品一致性评估技术和评估方法的局限性,提出了化妆品多维度一致性评估方法,通过同时检测产品整体品质(颜色、pH和光谱图等)和特性品质(防腐剂和功效成分等)等多个参数,创新性地设定合适的阈值和一致性折算方法,将结果整合... 介绍了现有化妆品一致性评估技术和评估方法的局限性,提出了化妆品多维度一致性评估方法,通过同时检测产品整体品质(颜色、pH和光谱图等)和特性品质(防腐剂和功效成分等)等多个参数,创新性地设定合适的阈值和一致性折算方法,将结果整合后以雷达图的形式直观呈现,使不同指标在同一判定标准体系下比较,准确反映出对照品和样品在配方体系和特征成分上的差异,帮助准确鉴别伪品。 展开更多
关键词 化妆品 检测 一致性 评估 多维度
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PPD皮肤试验和γ-干扰素释放试验在肺结核诊断及结核感染检测中的应用比较
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作者 李亚敏 高志东 +3 位作者 许春明 郭庆 任力争 周佳宇 《首都公共卫生》 2026年第1期57-61,共5页
目的 对比分析结核菌素纯蛋白衍生物(TB-PPD)皮肤试验和γ-干扰素释放试验(IGRA)结果的一致性,探讨在肺结核诊断和结核感染检测中的应用价值。方法 纳入2019年1月—2024年12月在北京市房山区结核病定点医疗机构就诊的初诊者684例,最终59... 目的 对比分析结核菌素纯蛋白衍生物(TB-PPD)皮肤试验和γ-干扰素释放试验(IGRA)结果的一致性,探讨在肺结核诊断和结核感染检测中的应用价值。方法 纳入2019年1月—2024年12月在北京市房山区结核病定点医疗机构就诊的初诊者684例,最终598例确诊为活动性肺结核患者。每例初诊者分别采用2 IU-PPD皮肤试验和IGRA进行平行检测,通过χ^(2)检验及一致性检验对两种检测方法的检测结果进行评价。结果 在所有初诊者中,PPD皮肤试验硬结平均直径≥10 mm为阳性标准时,PPD阳性率为83.5%,IGRA在所有初诊者中的阳性率为81.0%,两种检测方法阳性率接近。当进行活动性肺结核辅助诊断时,PPD皮肤试验硬结平均直径≥10 mm为阳性标准时,PPD皮肤试验对肺结核诊断的灵敏度为87.8%,特异度为46.5%,阳性预测值为91.9%,阴性预测值为35.4%;IGRA对肺结核诊断的灵敏度为84.9%,特异度为46.5%,阳性预测值为91.7%,阴性预测值为30.8%,以硬结平均直径≥10 mm为阳性标准时,PPD皮肤试验与IGRA对活动性肺结核的诊断效度接近。当进行结核分枝杆菌感染筛查时,PPD皮肤试验与IGRA检测结果一致率为70.8%~81.3%,Kappa值为0.241~0.286,当以硬结平均直径≥10 mm为阳性界值时,两种检测方法的一致率为78.8%,一致性检验差异无统计学意义(χ^(2)=1.993,P=0.158)。结论 当进行活动性肺结核辅助诊断或潜伏感染筛查时,建议以2 IU-PPD皮肤试验硬结平均直径≥10 mm为阳性界值。 展开更多
关键词 结核分枝杆菌 感染 PPD皮肤试验 Γ-干扰素释放试验 一致性检验
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扩散池法考察不同生产厂家糠酸莫米松乳膏的体外释放度
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作者 王经纬 鲍实 +3 位作者 陈晓颙 尚悦 刘晨曦 胡敏 《医药导报》 北大核心 2026年第1期109-115,共7页
目的建立测定糠酸莫米松乳膏体外释放度的实验方法,对参比制剂和国内8种糠酸莫米松乳膏仿制药的体外释放一致性进行评价。方法采用立式扩散池法测定糠酸莫米松乳膏的释放度,考察释放接收介质、滤膜、搅拌速率、温度等因素对糠酸莫米松... 目的建立测定糠酸莫米松乳膏体外释放度的实验方法,对参比制剂和国内8种糠酸莫米松乳膏仿制药的体外释放一致性进行评价。方法采用立式扩散池法测定糠酸莫米松乳膏的释放度,考察释放接收介质、滤膜、搅拌速率、温度等因素对糠酸莫米松乳膏体外释放行为的影响,比较国内8种糠酸莫米松乳膏仿制药与参比制剂体外释放行为之间的差异。采用释放介质为0.9%氯化钠溶液-乙醇(1:1),滤膜为孔径0.45μm的聚醚砜膜(PES膜),分别于1、3、5、7、12、24 h各取样1次,取样体积1 mL。以高效液相色谱法测定糠酸莫米松的浓度,采用C 16色谱柱(250 mm×4.6 mm,5μm),流动相为甲醇-水(70:30),检测波长254 nm,柱温40℃,流速1.0 mL·min^(-1),进样量20μL。结果方法学验证表明,体外释放方法的滤膜惰性、专属性、灵敏度、选择性均符合要求。糠酸莫米松的定量限为0.2μg·mL^(-1),在0.2~20.0μg·mL^(-1)范围内线性良好(r^(2)=0.99999),回收率为97.1%,稳定性和重复性均良好。参比制剂24 h的释放百分比为1.41%,8种仿制药的释放度为1.93%~62.26%。结论建立的体外释放实验方法准确度好、灵敏度高,可为糠酸莫米松乳膏优化处方、生产工艺及一致性评价提供参考。 展开更多
关键词 糠酸莫米松乳膏 立式扩散池法 体外释放 参比制剂 一致性评价
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CT图像划定腰椎间盘突出症密歇根州立大学分型的可行性分析
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作者 顾幸 白贵文 +2 位作者 王胜 魏培韵 张仲宁 《颈腰痛杂志》 2026年第1期60-65,共6页
目的 分析CT与MRI图像上腰椎间盘突出症密歇根州立大学(MSU)分型的一致性,确定CT图像划定该分型的可行性。方法 回顾性分析2018年1月1日至2023年12月31日在郑州大学第二附属医院以腰椎间盘突出症为诊断住院,且同时具备本院完整腰椎MRI... 目的 分析CT与MRI图像上腰椎间盘突出症密歇根州立大学(MSU)分型的一致性,确定CT图像划定该分型的可行性。方法 回顾性分析2018年1月1日至2023年12月31日在郑州大学第二附属医院以腰椎间盘突出症为诊断住院,且同时具备本院完整腰椎MRI及CT图像的197例患者病历资料。首先将全部影像数据分为MRI组和CT组,并随机编号;再由3位医师作为观察者,盲法划定两组影像数据的MSU分型;最后采用Fleiss'Kappa系数评估3位观察者划定结果的一致性,采用Cohen's Kappa系数评估CT和MRI图像划定结果的一致性,并分别验证其统计学显著性。结果 197份MRI图像中,191份分型一致;197份CT图像中,186份分型一致;Fleiss'Kappa系数为:MRI(0.973)、CT(0.951)。剔除不能配对的图像后得到181份病例。其中,CT与MRI结果完全一致的有169例,Cohen's Kappa系数为0.913。结论 CT图像划定MSU分型的能力与MRI图像相当,对于存在体内金属内置物的患者,或因需紧急评估骨性压迫(如骨折、钙化型椎间盘突出)及快速诊断急性马尾综合征的情况,CT检查可作为MRI的有效替代或补充。 展开更多
关键词 腰椎间盘突出症 密歇根州立大学分型 影像学诊断 CT图像 MRI图像 一致性检验
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Checking Adequacy of Variance Function in Nonparametric Regression with Unknown Mean Function
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作者 LIANG Jia SONG Weixing SHI Jianhong 《Journal of Systems Science & Complexity》 2026年第1期88-114,共27页
In this paper,the authors propose a class of test procedures to check the fitness of parametric forms of the variance function in regression models when the mean function is unknown.By evaluating the unknown mean func... In this paper,the authors propose a class of test procedures to check the fitness of parametric forms of the variance function in regression models when the mean function is unknown.By evaluating the unknown mean function with the classical kernel estimator,the proposed test statistics are built upon a modified minimum distance between a nonparametric fit and a parametric estimator under the null hypothesis for the variance function.Asymptotic properties of the estimator of the parameters in the variance function are discussed,and the large sample distribution of the test statistics under the null hypothesis is established,as well as the consistency and the power under some local alternative hypotheses.Extensive numerical studies demonstrate that the proposed test procedures have satisfactory finite sample performance.Finally,two real data examples further showcase the effectiveness of the proposed test in real applications. 展开更多
关键词 consistency and local power heterogeneity test minimum distance variance function
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基于国家药品抽检的缩宫素注射液质量评价
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作者 刘梦媛 于珊 +1 位作者 佘学慧 陆益红 《医药导报》 北大核心 2026年第2期224-229,共6页
目的基于国家药品抽检工作,对缩宫素注射液的质量现状进行分析,为该品种的质量控制及质量标准的完善提供参考和建议。方法对抽检的162批次样品采用法定标准进行检验,针对检验中发现的问题开展有关物质、聚合物及含量测定等项目的探索性... 目的基于国家药品抽检工作,对缩宫素注射液的质量现状进行分析,为该品种的质量控制及质量标准的完善提供参考和建议。方法对抽检的162批次样品采用法定标准进行检验,针对检验中发现的问题开展有关物质、聚合物及含量测定等项目的探索性研究,重点关注是否通过一致性评价(过评)样品的质量差异。结果按照法定标准检验162批次样品,合格率100.0%,但发现现行药典标准存在缺少有关物质、聚合物专属控制项等问题。探索性研究结果表明,过评样品杂质与聚合物控制情况总体较好,仅1个持有人样品未知杂质与聚合物含量略高,由原料引入;在有关物质项下控制二聚体尚不能完全表征聚合物的含量;未过评样品杂质与聚合物水平高于过评样品。结论过评缩宫素注射液总体质量较好,优于未过评样品,各注册标准质量控制较完善。建议持有人加强原料控制,选择优质固相合成原料,完善降解杂质与聚合物的控制。 展开更多
关键词 缩宫素注射液 国家药品抽检 一致性评价 质量评价 有关物质 聚合物
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国产盐酸硫必利片有关物质的现状分析
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作者 朱晓月 张树栋 +5 位作者 朱雪彬 吴兆伟 吴斌 郑洁 王珊 张喆 《药物分析杂志》 北大核心 2026年第1期156-165,共10页
目的:建立HPLC法测定盐酸硫必利原料和片剂中的9个杂质,弥补现行方法缺陷,从杂质种类、来源、含量3个方面对国产仿制药和参比制剂进行评价,阐明降低样品中主要杂质的方法。方法:采用Waters Xbridge C_(18)色谱柱(250 mm×4.6 mm,5μ... 目的:建立HPLC法测定盐酸硫必利原料和片剂中的9个杂质,弥补现行方法缺陷,从杂质种类、来源、含量3个方面对国产仿制药和参比制剂进行评价,阐明降低样品中主要杂质的方法。方法:采用Waters Xbridge C_(18)色谱柱(250 mm×4.6 mm,5μm),柱温35℃,以0.1%浓氨溶液-甲醇为流动相,进行梯度洗脱,流速1.0 mL·min^(-1),检测波长240 nm,进样体积10μL。结果:硫必利及各杂质的线性范围在0.1~10μg·mL^(-1)(r>0.9999);定量限在0.054~0.103μg·mL^(-1),检测限在0.015~0.031μg·mL^(-1);硫必利及各杂质的溶液在24 h内稳定。盐酸硫必利结构稳定,杂质D为主要的降解杂质,8个杂质来源于工艺。抽检的133批样品中,新发现的工艺杂质H含量最高。国内仿制制剂杂质含量水平与参比制剂基本一致。结论:本研究建立的有关物质HPLC方法简便、准确、灵敏、高效,国抽样品测定结果表明目前国产盐酸硫必利片杂质控制水平较好,与参比制剂基本一致,企业可通过提高原料合成工艺以降低原料及制剂中的主要杂质,本研究成果为盐酸硫必利及其制剂的科学监管提供了有力的技术支撑。 展开更多
关键词 国家药品抽检 盐酸硫必利片 有关物质 杂质溯源 高效液相色谱 仿制药一致性评价 提高药品质量
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