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首页> 外文期刊>International Journal of Environmental Research and Public Health >Prospective Power Calculations for the Four Lab Study of A Multigenerational Reproductive/Developmental Toxicity Rodent Bioassay Using A Complex Mixture of Disinfection By-Products in the Low-Response Region
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Prospective Power Calculations for the Four Lab Study of A Multigenerational Reproductive/Developmental Toxicity Rodent Bioassay Using A Complex Mixture of Disinfection By-Products in the Low-Response Region

机译：在低响应区域使用消毒副产物的复杂混合物进行多代生殖/发育毒性啮齿动物生物测定的四个实验室研究的前瞻性功率计算

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In complex mixture toxicology, there is growing emphasis on testing environmentally representative doses that improve the relevance of results for health risk assessment, but are typically much lower than those used in traditional toxicology studies. Traditional experimental designs with typical sample sizes may have insufficient statistical power to detect effects caused by environmentally relevant doses. Proper study design, with adequate statistical power, is critical to ensuring that experimental results are useful for environmental health risk assessment. Studies with environmentally realistic complex mixtures have practical constraints on sample concentration factor and sample volume as well as the number of animals that can be accommodated. This article describes methodology for calculation of statistical power for non-independent observations for a multigenerational rodent reproductive/developmental bioassay. The use of the methodology is illustrated using the U.S. EPA’s Four Lab study in which rodents were exposed to chlorinated water concentrates containing complex mixtures of drinking water disinfection by-products. Possible experimental designs included two single-block designs and a two-block design. Considering the possible study designs and constraints, a design of two blocks of 100 females with a 40:60 ratio of control:treated animals and a significance level of 0.05 yielded maximum prospective power (~90%) to detect pup weight decreases, while providing the most power to detect increased prenatal loss.
机译：在复杂的混合物毒理学中，越来越强调测试环境代表性的剂量，这些剂量可改善结果与健康风险评估的相关性，但通常比传统毒理学研究中使用的剂量低得多。具有典型样本量的传统实验设计可能没有足够的统计能力来检测环境相关剂量引起的影响。适当的研究设计和足够的统计能力，对于确保实验结果对环境健康风险评估有用至关重要。对环境现实的复杂混合物的研究对样品的浓缩系数和样品量以及可容纳的动物数量有实际的限制。本文介绍了用于多代啮齿动物生殖/发育生物测定的非独立观察的统计功效的计算方法。美国EPA的“四实验室”研究对这种方法的使用进行了说明，在该研究中，啮齿动物暴露于含有饮用水消毒副产物复杂混合物的氯化水浓缩物中。可能的实验设计包括两个单块设计和两个块设计。考虑到可能的研究设计和约束条件，设计两块100只雌性动物的设计，其中对照：治疗动物的比例为40:60，显着性水平为0.05，从而产生最大的前瞻能力（〜90％）来检测幼犬的体重下降，同时提供最有力的发现产前损失增加。

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