中文摘要：等价性检验可用来评估监管产品的安全性利用历史研究中得到的相关数据监管产品的安全性。本文将转基因玉米和参考玉米用于动物饲料研究的一系列数据来证实该方法。首先讨论了等价性量化的几个准则，并选择合适的分布等效性作为研究的实例。本文提出了一种等价性检验方法，该方法利用广义置信推理方法，综合了历史数据和当前数据的不确定性。
外文摘要：An equivalence testing method is described to assess the safety of regulated products using relevant data obtained in historical studies with assumedly safe reference products. The method is illustrated using data from a series of animal feeding studies with genetically modified and reference maize varieties. Several criteria for quantifying equivalence are discussed, and study-corrected distribution-wise equivalence is selected as being appropriate for the example case study. An equivalence test is proposed based on a high probability of declaring equivalence in a simplified situation, where there is no between-group variation, where the historical and current studies have the same residual variance, and where the current study is assumed to have a sample size as set by a regulator. The method makes use of generalized fiducial inference methods to integrate uncertainties from both the historical and the current data. (C) 2017 The Authors. Published by Elsevier Ltd.
外文关键词：Food safety; Average equivalence; Distribution-wise equivalence; Linear mixed model; Generalized fiducial inference; Statistical power
作者：van der Voet, Hilko; Goedhart, Paul W.; Schmidt, Kerstin
作者单位：Wageningen Univ & Res
期刊名称：FOOD AND CHEMICAL TOXICOLOGY
期刊影响因子：3.778
出版年份：2017
出版刊次：11
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