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首页> 外文期刊>Environmental toxicology and chemistry >TESTS FOR BIOEQUIVALENCE OF CONTROL MEDIA AND TEST MEDIA IN STUDIES OF TOXICITY
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TESTS FOR BIOEQUIVALENCE OF CONTROL MEDIA AND TEST MEDIA IN STUDIES OF TOXICITY

机译:毒性研究中控制培养基和试验培养基的生物等效性测试

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摘要

Statistical tests of the classical (null) hypothesis—that there is no difference in effects of control media and test media— are commonly used to make statistical inferences toward the no-observed-adverse-effect concentration. However, failing to reject this hypothesis is not considered as scientific proof the hypothesis is true. An effect may exist, but high variation due to inadequate replication, variation in experimental units, or imprecise measurement techniques may yield data for which the hypothesis is not rejected. An experiment may also be too precise, yielding effects that are statistically significant but not biologically important. We propose the use of tests of bioequivalence of control media and test media to alleviate these unsatisfactory characteristics of tests of the classical hypotheses for regulatory decisions. We review and illustrate the test for bioequivalence using acute and chronic toxicity data. We also define a procedure for determining the level of effect at which there will be high power to refute the hypothesis that there is a lack of bioequivalence if in fact the biological response in the control media is identical to the response in the test media.
机译:对经典(无效)假设的统计检验(对照介质和检验介质的效果没有差异)通常用于对未观察到的不良影响浓度进行统计推断。但是,未能拒绝该假设不被视为科学依据,该假设是正确的。可能存在效果,但是由于复制不充分,实验单位的差异或不精确的测量技术而导致的高差异可能会产生无法拒绝其假设的数据。实验也可能过于精确,产生的效果在统计上是有意义的,但在生物学上却不重要。我们建议使用控制介质和测试介质的生物等效性测试来缓解经典假设的测试对于监管决策的这些不令人满意的特征。我们审查和说明使用急性和慢性毒性数据的生物等效性测试。如果实际上控制培养基中的生物学反应与测试培养基中的反应相同,我们还定义了一种程序来确定影响水平,在该水平上将有较高的能力来驳斥缺乏生物等效性的假设。

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