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Recommendations for harmonization of data collection and analysis of developmental neurotoxicity endpoints in regulatory guideline studies: Proceedings of workshops presented at Society of Toxicology and joint Teratology Society and Neurobehavioral Teratology Society meetings

机译:监管指南研究中有关数据收集和发育性神经毒性终点分析的统一建议:在毒理学学会和联合畸形学会和神经行为畸形学会会议上举办的研讨会的会议记录

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摘要

The potential for developmental neurotoxicity (DNT) of environmental chemicals may be evaluated using specific test guidelines from the US Environmental Protection Agency or the Organisation for Economic Cooperation and Development (OECD). These guidelines generate neurobehavioral, neuropathological, and morphometric data that are evaluated by regulatory agencies globally. Data from these DNT guideline studies, or the more recent OECD extended one-generation reproductive toxicity guideline, play a pivotal role in children’s health risk assessment in different world areas. Data from the same study may be interpreted differently by regulatory authorities in different countries resulting in inconsistent evaluations that may lead to inconsistencies in risk assessment decisions internationally, resulting in regional differences in public health protection or in commercial trade barriers. These issues of data interpretation and reporting are also relevant to juvenile and pre-postnatal studies conducted more routinely for pharmaceuticals and veterinary medicines. There is a need for development of recommendations geared toward the operational needs of the regulatory scientific reviewers who apply these studies in risk assessments, as well as the scientists who generate DNT data sets. The workshops summarized here draw upon the experience of the authors representing government, industry, contract research organizations, and academia to discuss the scientific issues that have emerged from diverse regulatory evaluations. Although various regulatory bodies have different risk management decisions and labeling requirements that are difficult to harmonize, the workshops provided an opportunity to work toward more harmonized scientific approaches for evaluating DNT data within the context of different regulatory frameworks. Five speakers and their coauthors with neurotoxicology, neuropathology, and regulatory toxicology expertise discussed issues of variability, data reporting and analysis, and expectations in DNT data that are encountered by regulatory authorities. In addition, principles for harmonized evaluation of data were suggested using guideline DNT data as case studies.
机译:可以使用来自美国环境保护署或经济合作与发展组织(OECD)的特定测试指南来评估环境化学物质发生发育性神经毒性(DNT)的可能性。这些准则生成了神经行为,神经病理学和形态计量学数据,这些数据已被全球监管机构评估。这些DNT指南研究或最近的OECD扩展的一代生殖毒性指南中的数据,在世界不同地区的儿童健康风险评估中起着关键作用。来自同一研究的数据在不同国家/地区的监管机构可能会有不同的解释,从而导致评估结果不一致,从而可能导致国际上的风险评估决策不一致,从而导致公共卫生保护或商业贸易壁垒出现地区差异。这些数据解释和报告问题也与针对药物和兽药进行的更常规的青少年和产后研究有关。有必要针对针对将这些研究应用到风险评估中的监管科学审查员以及生成DNT数据集的科学家的操作需求而制定建议。这里总结的研讨会借鉴了代表政府,行业,合同研究组织和学术界的作者的经验,讨论了各种监管评估中出现的科学问题。尽管各个监管机构都有不同的风险管理决策和标签要求,难以统一,但研讨会为在不同监管框架下评估DNT数据的更加统一的科学方法提供了机会。五位演讲者及其合著者具有神经毒理学,神经病理学和监管毒理学专业知识,讨论了监管机构遇到的可变性,数据报告和分析以及对DNT数据的期望等问题。此外,还建议使用指导性DNT数据作为案例研究来统一评估数据的原则。

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