Testing Statistical Hypotheses of Equivalence and Noninferiority
Testing Statistical Hypotheses of Equivalence and Noninferiority
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DOI：
10.1201/ebk1439808184
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发表时间：
2010-06
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影响因子：
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通讯作者：
S. Wellek
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作者：
S. Wellek
引言 等效性和非劣效性概念的统计意义 证明等效性是应用统计学的基本问题 等效性检验的主要应用领域 等效性/非劣效性研究在当前医学研究中的作用 提出假设 选择主要分布参数 等效性极限的数值规范 处理非劣效性问题的一般技术 位置参数族情况下的标准解 构造精确最优检验的方法位置移动模型之外的设置 针对精确构造无法访问的问题的大样本解决方案 客观贝叶斯方法 改进离散分布的非随机检验 非劣性检验和两侧等价检验之间的关系 将 alpha 减半？构建严格意义上的等价检验的一般方法 置信区间包含原理 双边等价的贝叶斯检验 导出等价假设的最佳参数检验的经典方法 构建等价的渐近检验 选定单参数问题的等价检验 已知方差正态分布观测值的单样本问题 测试风险率与某个给定参考值的等价性，生存时间呈指数分布单个二项式比例与固定参考成功概率的等价性 置信区间包含规则作为等价性的渐近 UMP 检验 本章导出的检验的非劣效性类似物 成对观测设计的等价性检验 等价性的符号检验 McNemar 设置的等价性检验 等价性的配对 t 检验 等价性的符号秩检验 等价性的符号秩检验的推广用于非连续数据 两个不相关样本的等价检验 等价的双样本 t 检验 等价的 Mann-Whitney 检验 基于线性秩统计的双样本等价检验 允许任意关系模式的无分布双样本等价检验 测试两个高斯分布的离散等价性 两个二项式样本的等价检验 两个幸存者函数等价性的对数秩检验 多样本等价检验交集原理作为多样本等价问题的通用解决方案 k 正态分布等价性的 F 检验 等价性的改进学生化极差检验 两个以上高斯分布的离散等价性测试 等价性的非参数 k 样本检验 多元数据的等价性检验 正态分布中多个相关样本的等价性检验 等价性的多元两样本检验 建立拟合优度的检验 单个数据的等价性检验具有完全指定的参考分布的多项分布 测试多路列联表的近似折叠性 建立正态分布数据的线性模型的拟合优度 测试基因型分布与 Hardy-Weinberg 条件的近似兼容性 生物等效性评估 简介 平均生物等效性的测试方法 个体生物等效性：标准和测试程序 定义和建立群体生物等效性的方法 生物等效性评估作为比较二元分布的问题处理之间的相关差异 引言 利用双边等价检验与相关差异存在之间的对偶性 相关差异检验的一些特殊问题的解决方案 附录 A：基本理论结果 附录 B：特殊计算机程序列表 附录 C：常用特殊符号和缩写 参考文献 作者索引 主题索引
Introduction Statistical meaning of the concepts of equivalence and noninferiority Demonstration of equivalence as a basic problem of applied statistics Major fields of application of equivalence tests Role of equivalence/noninferiority studies in current medical research Formulation of hypotheses Choosing the main distributional parameter Numerical specification of the limits of equivalence General Techniques for Dealing with Noninferiority Problems Standard solution in the case of location parameter families Methods of constructing exact optimal tests for settings beyond the location-shift model Large-sample solutions for problems inaccessible for exact constructions Objective Bayesian methods Improved nonrandomized tests for discrete distributions Relationship between tests for noninferiority and two-sided equivalence tests Halving alpha? General Approaches to the Construction of Tests for Equivalence in the Strict Sense The principle of confidence interval inclusion Bayesian tests for two-sided equivalence The classical approach to deriving optimal parametric tests for equivalence hypotheses Construction of asymptotic tests for equivalence Equivalence Tests for Selected One-Parameter Problems The one-sample problem with normally distributed observations of known variance Test for equivalence of a hazard rate to some given reference value with exponentially distributed survival times Testing for equivalence of a single binomial proportion to a fixed reference success probability Confidence-interval inclusion rules as asymptotically UMP tests for equivalence Noninferiority analogues of the tests derived in this chapter Equivalence Tests for Designs with Paired Observations Sign test for equivalence Equivalence tests for the McNemar setting Paired t-test for equivalence Signed rank test for equivalence A generalization of the signed rank test for equivalence for noncontinuous data Equivalence Tests for Two Unrelated Samples Two-sample t-test for equivalence Mann-Whitney test for equivalence Two-sample equivalence tests based on linear rank statistics A distribution-free two-sample equivalence test allowing for arbitrary patterns of ties Testing for dispersion equivalence of two Gaussian distributions Equivalence tests for two binomial samples Log-rank test for equivalence of two survivor functions Multisample Tests for Equivalence The intersection-union principle as a general solution to multisample equivalence problems F-test for equivalence of k normal distributions Modified studentized range test for equivalence Testing for dispersion equivalence of more than two Gaussian distributions A nonparametric k-sample test for equivalence Equivalence Tests for Multivariate Data Equivalence tests for several dependent samples from normal distributions Multivariate two-sample tests for equivalence Tests for Establishing Goodness of Fit Testing for equivalence of a single multinomial distribution with a fully specified reference distribution Testing for approximate collapsibility of multiway contingency tables Establishing goodness of fit of linear models for normally distributed data Testing for approximate compatibility of a genotype distribution with the Hardy-Weinberg condition The Assessment of Bioequivalence Introduction Methods of testing for average bioequivalence Individual bioequivalence: criteria and testing procedures Approaches to defining and establishing population bioequivalence Bioequivalence assessment as a problem of comparing bivariate distributions Tests for Relevant Differences between Treatments Introduction Exploiting the duality between testing for two-sided equivalence and existence of relevant differences Solutions to some special problems of testing for relevant differences Appendix A: Basic Theoretical Results Appendix B: List of Special Computer Programs Appendix C: Frequently Used Special Symbols and Abbreviations References Author Index Subject Index