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ESAC Opinion on the SkinEthic™ Human Corneal Epithelium (HCE) Eye Irritation Test (EIT)

机译:ESAC关于SkinEthic™人角膜上皮(HCE)眼刺激试验(EIT)的意见

摘要

ESAC, the EURL ECVAM Scientific Advisory Committee, advises EURL ECVAM on scientific issues. Its main role is to conduct independent peer review of validation studies of alternative test methods and to assess their scientific validity for a given purpose. The committee reviews the appropriateness of study design and management, the quality of results obtained and the plausibility of the conclusions drawn. ESAC peer reviews are formally initiated with a EURL ECVAM Request for ESAC Advice, which provides the necessary background for the peer-review and establishes its objectives, timelines and the questions to be addressed. The peer review is normally prepared by specialised ESAC Working Groups. These are typically composed of ESAC members and other external experts relevant to the test method under review. These experts may be nominated by ESAC, EURL ECVAM and partner organisations within the International Cooperation on Alternative Test Methods (ICATM). ESAC ultimately decides on the composition of these Working Groups. ESAC's advice to EURL ECVAM is formally provided as 'ESAC Opinions' and 'Working Group Reports' at the end of the peer review. ESAC may also issue Opinions on other scientific issues of relevance to the work and mission of EURL ECVAM but not directly related to a specific alternative test method.The ESAC Opinion expressed in this report relates to the peer-review of the SkinEthic™ Human Corneal Epithelium (HCE) Eye Irritation Test (EIT).
机译:ESAC,即EURL ECVAM科学咨询委员会,就科学问题为EURL ECVAM提供咨询。它的主要作用是对替代测试方法的验证研究进行独立的同行评审,并评估其在特定目的下的科学有效性。该委员会审查研究设计和管理的适当性,所获得结果的质量以及所得出结论的合理性。 ESAC同行评审是通过EURL ECVAM ESAC咨询请求正式启动的,该请求为同行评审提供了必要的背景,并确定了其目标,时间表和要解决的问题。同行评审通常由专门的ESAC工作组准备。这些人员通常由ESAC成员和与正在检查的测试方法相关的其他外部专家组成。这些专家可能由ESAC,EURL ECVAM和国际替代测试方法合作组织(ICATM)内的合作伙伴提名。 ESAC最终决定这些工作组的组成。在同行评审结束时,ESAC对EURL ECVAM的建议正式以“ ESAC意见”和“工作组报告”的形式提供。 ESAC可能还会就与EURL ECVAM的工作和任务有关但与特定替代测试方法没有直接关系的其他科学问题发表意见。本报告中表达的ESAC意见与SkinEthic™人角膜上皮的同行评审有关(HCE)眼睛刺激测试(EIT)。

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