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21 世纪毒理学测试的培训需求:一项基于调查的分析。

Training needs for toxicity testing in the 21st century: a survey-informed analysis.

机构信息

Systems Toxicology Unit, Institute for Health and Consumer Protection, Joint Research Centre, European Commission, Ispra, Varese, Italy.

出版信息

Altern Lab Anim. 2012 Dec;40(6):313-20. doi: 10.1177/026119291204000604.

Abstract

Current training needs on the use of alternative methods in predictive toxicology, including new approaches based on mode-of-action (MoA) and adverse outcome pathway (AOP) concepts, are expected to evolve rapidly. In order to gain insight into stakeholder preferences for training, the European Commission's Joint Research Centre (JRC) conducted a single-question survey with twelve experts in regulatory agencies, industry, national research organisations, NGOs and consultancies. Stakeholder responses were evaluated by means of theory-based qualitative data analysis. Overall, a set of training topics were identified that relate both to general background information and to guidance for applying alternative testing methods. In particular, for the use of in silico methods, stakeholders emphasised the need for training on data integration and evaluation, in order to increase confidence in applying these methods for regulatory purposes. Although the survey does not claim to offer an exhaustive overview of the training requirements, its findings support the conclusion that the development of well-targeted and tailor-made training opportunities that inform about the usefulness of alternative methods, in particular those that offer practical experience in the application of in silico methods, deserves more attention. This should be complemented by transparent information and guidance on the interpretation of the results generated by these methods and software tools.

摘要

目前,关于替代方法在预测毒理学中的应用的培训需求,包括基于作用模式(MoA)和不良结局途径(AOP)概念的新方法,预计将迅速发展。为了深入了解利益相关者对培训的偏好,欧盟委员会联合研究中心(JRC)对来自监管机构、行业、国家研究组织、非政府组织和咨询公司的 12 名专家进行了一项单问题调查。通过基于理论的定性数据分析来评估利益相关者的回应。总体而言,确定了一系列与一般背景信息和替代测试方法应用指南相关的培训主题。特别是对于计算方法的使用,利益相关者强调需要培训数据集成和评估,以提高将这些方法应用于监管目的的信心。尽管该调查并未声称提供培训需求的详尽概述,但调查结果支持以下结论,即需要开发有针对性和定制的培训机会,以告知替代方法的实用性,特别是那些提供计算方法应用实践经验的方法,值得更多关注。这应辅以有关这些方法和软件工具生成的结果的透明信息和指导。

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