Testing the similarity of two normal populations with application to the bioequivalence problem

Bayoud Husam Awni

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Testing the similarity of two normal populations with application to the bioequivalence problem

机译：测试两个正常人群的相似性并将其应用于生物等效性问题

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摘要

The problem of testing the similarity of two normal populations is reconsidered, in this article, from a nonclassical point of view. We introduce a test statistic based on the maximum likelihood estimate of Weitzman's overlapping coefficient. Simulated critical points are provided for the proposed test for various sample sizes and significance levels. Statistical powers of the proposed test are computed via simulation studies and compared to those of the existing tests. Furthermore, Type-I error robustness of the proposed and the existing tests are studied via simulation studies when the underlying distributions are non-normal. Two data sets are analyzed for illustration purposes. Finally, the proposed test has been implemented to assess the bioequivalence of two drug formulations.

机译：从非经典的角度来看，本文重新考虑了测试两个正常总体相似性的问题。我们基于韦茨曼重叠系数的最大似然估计引入检验统计量。为建议的测试提供了模拟的临界点，用于各种样本大小和显着性水平。拟议测试的统计能力是通过模拟研究计算得出的，并与现有测试的统计能力进行比较。此外，当基础分布为非正态分布时，通过模拟研究来研究所提出的和现有测试的I型错误鲁棒性。为了说明目的，分析了两个数据集。最后，建议的测试已经实施，以评估两种药物制剂的生物等效性。

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来源
《Journal of applied statistics》 |2016年第8期|1322-1334|共13页
作者
Bayoud Husam Awni;
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作者单位

Fahad Bin Sultan Univ, Coll Sci & Humanities, Tabuk 71454, Saudi Arabia;

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原文格式 PDF
正文语种 eng
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关键词
bioequivalence; likelihood ratio test; MLE; overlapping coefficient; statistical power;

机译：生物等效性;似然比检验;MLE;重叠系数;统计功效;

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1. Performance evaluation of likelihood-ratio tests for assessing similarity of the covariance matrices of two multivariate normal populations [J] . Najarzadeh D., Khazaei M., Ganjali M. Communications in Statistics . 2016,第5a6期

机译：评估两种多元普通群体协方差矩阵相似性的似然比测试的性能评估
2. Equivalence testing for similarity in bioassays using bioequivalence criteria on the relative bioactivity [J] . Baljé‐Volkers Corine, Mzolo Thembile, Talens Erik, Pharmaceutical statistics. . 2018,第1期

机译：使用生物等效标准对相对生物活性的生物测定中的相似性等效测试
3. Establishing virtual bioequivalence and clinically relevant specifications using in vitro biorelevant dissolution testing and physiologically-based population pharmacokinetic modeling. case example: Naproxen [J] . European journal of pharmaceutical sciences . 2020,第期

机译：使用体外Biorelevant溶出试验和基于生理学的人口药代动力学建模建立虚拟生物等效和临床相关规范。案例示例：naproxen
4. The 1st Workshop on Testing Technologies and Tools for Critical Industry Applications A Safe Approach to Shrink Email Sample Set while Keeping Balance between Spam and Normal [C] . Lili Diao, Hao Wang 2009 third IEEE international conference on secure integration and reliability improvement . 2009

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5. Selection and testing designs for selecting one among k normal populations, provided it is better than a standard. [D] . Rollin, Linda M. 2002

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6. A mechanistic pharmacokinetic model with drug and antidrug antibody interplay and its application for assessing the impact of immunogenicity response on bioequivalence testing [O] . Kai H. Liao, Chandrasekhar Udata, Donghua Yin, 2020

机译：具有药物和抗皱抗体相互作用的机械药代理模型及其在评估免疫原性反应对生物等效测试的影响
7. A Nonparametric Test for Similarity of Marginals- with Applications to the Assessment of Population Bioequivalence [O] . Gudrun Freitag A 2008

机译：边缘相似性的非参数检验 - 及其在人口生物等效性评估中的应用
8. Likelihood Ratio Tests on Covariance Matrices and Mean Vectors of Complex Multivariate Normal Populations and Their Applications in Time Series [R] . Krishnaian, P. R., Lee, J. C., Chang, T. C. 1983

机译：似然比检验复变多元正规总体的协方差矩阵和均值向量及其在时间序列中的应用

Testing the similarity of two normal populations with application to the bioequivalence problem

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