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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毒性测试在不断发展！

在当今社会，对不断增加的化学物质数量进行有效管理比以往任何时候都更为重要。毒性测试在旨在保护公众和环境免受这些多种化学物质的潜在有害或不利影响的机构和政府的监管决策中起着关键作用。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，毒性测试方法是基于对实验动物的研究。然而，在过去的20年中，人们越来越关注这些方法的可持续性。这就产生了开发满足监管要求并为社会所接受和负担得起的新方法的真正需求。为了解决这一关键需求，世界范围内已经采取了许多举措。但是，尽管现在已经有支持这一点的科学，但是NAM接受的立法和步伐仍然落后。这次审查将考虑欧洲为识别NAM而取代或完善当前药物毒性测试方法的各种举措中的一些举措。本文还提出了一种新颖的系统方法来支持21世纪应有的所需毒性测试方法。但是，尽管现在已经有支持这一点的科学，但是NAM接受的立法和步伐仍然落后。这次审查将考虑欧洲为识别NAM而取代或完善当前药物毒性测试方法的各种举措中的一些举措。本文还提出了一种新颖的系统方法来支持21世纪应有的所需毒性测试方法。但是，尽管现在已经有支持这一点的科学，但是NAM接受的立法和步伐仍然落后。这次审查将考虑欧洲为识别NAM而取代或完善当前药物毒性测试方法的各种举措中的一些举措。本文还提出了一种新颖的系统方法来支持21世纪应有的所需毒性测试方法。