The efficient management of the continuously increasing number of chemical substances used in today's society is assuming greater importance than ever before. Toxicity testing plays a key role in the regulatory decisions of agencies and governments that aim to protect the public and the environment from the potentially harmful or adverse effects of these multitudinous chemicals. Therefore, there is a critical need for reliable toxicity-testing methods to identify, assess and interpret the hazardous properties of any substance. Traditionally, toxicity-testing approaches have been based on studies in experimental animals. However, in the last 20 years, there has been increasing concern regarding the sustainability of these methodologies. This has created a real need for the development of new approach methodologies (NAMs) that satisfy the regulatory requirements and are acceptable and affordable to society. Numerous initiatives have been launched worldwide in attempts to address this critical need. However, although the science to support this is now available, the legislation and the pace of NAMs acceptance is lagging behind. This review will consider some of the various initiatives in Europe to identify NAMs to replace or refine the current toxicity-testing methods for pharmaceuticals. This paper also presents a novel systematic approach to support the desired toxicity-testing methodologies that the 21st century deserves.

中文翻译：

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毒性测试正在不断发展！


当今社会使用的化学物质数量不断增加，有效管理比以往任何时候都更加重要。毒性测试在机构和政府的监管决策中发挥着关键作用，旨在保护公众和环境免受这些众多化学品的潜在有害或不利影响。因此，迫切需要可靠的毒性测试方法来识别、评估和解释任何物质的危险特性。传统上，毒性测试方法基于实验动物研究。然而，在过去 20 年里，人们越来越关注这些方法的可持续性。这确实需要开发新的方法论（NAM），以满足监管要求并且为社会所接受和负担得起。世界各地发起了许多举措，试图满足这一迫切需求。然而，尽管现在已经有了支持这一点的科学依据，但 NAM 的立法和接受速度仍然滞后。本次审查将考虑欧洲的一些旨在确定 NAM 的举措，以取代或完善当前的药物毒性测试方法。本文还提出了一种新颖的系统方法来支持 21 世纪所需的毒性测试方法。