In vitro toxicology methods: impact on regulation from technical and scientific advancements
In vitro toxicology methods: impact on regulation from technical and scientific advancements
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DOI：
10.1016/s0378-4274(01)00495-7
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发表时间：
2002-02-28
影响因子：
3.5
通讯作者：
Zucco, F
中科院分区：
文献类型：
--
作者：
Carere, A;Stammati, A;Zucco, F
生物医学研究，特别是体外实验模型领域的技术进步令人印象深刻，为共培养、微团或干细胞培养开辟了新的可能性。还可获得用于研究特定靶标和/或机制的工程化细胞。此外，最近的基因组学和蛋白质组学技术代表了毒理学效应研究中一种非常微妙的方法。从所有这些方法中可以建立新的基于机械的方法，这些方法一旦得到验证，就可以进入监管程序。到目前为止，在毒理学方面，只有少数体外试验被接受用于监管目的，例如与腐蚀，光毒性和吸收有关的试验。其他许多项目正处于预验证或验证阶段。体外试验发挥关键作用的一个领域是遗传毒理学。在此背景下，将介绍最新的测试策略和测试方法，特别关注欧盟食品科学委员会最近更新的食品添加剂指南。如果在国家和国际一级更好地协调这一事项，协调不同的立法，严格控制国家规则，使其在经验证的方法方面与时俱进，就可能改进经验证的方法的实施。(C)2002年由Elsevier Science爱尔兰有限公司出版。
The impressive advancement of technologies in biomedical research, and particularly in the area of in vitro experimental models, has opened up new possibilities related to co-cultures, micromass or stem cell cultures. Engineered cells to study specific targets and/or mechanisms are also available. Moreover, a very subtle approach in the study of toxicological effects is represented by the very recent genomics and proteomics techniques. New mechanistically based methods could be established from all these approaches, which, once validated, could enter the regulatory procedure. So far, in toxicology, only a few in vitro tests are accepted for regulatory purposes, such as those related to corrosion, phototoxicity and absorption. Many others are in the pre-validation or validation phase. An area where in vitro tests play a key role is the genetic toxicology. In this context, the most recent testing strategies and test methods will be presented, with particular attention to the recently updated guidelines for food additives by the EU Scientific Committee on Food. An improvement in the implementation of validated methods could arise from a better coordination on the matter at national and international levels, the harmonisation of different legislations, and a strict control of the national rules in order to make them up-to-date with respect to validated methods. (C) 2002 Published by Elsevier Science Ireland Ltd.