Hartung Thomas
Center for Alternatives to Animal Testing, Department for Environmental Health Sciences, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD 21231, USA.
Toxicol Sci. 2009 May;109(1):18-23. doi: 10.1093/toxsci/kfp059. Epub 2009 Apr 8.
The landmark publication by the National Research Council putting forward a vision of a toxicology for the 21st century in 2007 has created an atmosphere of departure in our field. The alliances formed, symposia and meetings held and the articles following are remarkable, indicating that this is an idea whose time has come. Most of the discussion centers on the technical opportunities to map pathways of toxicity and the financing of the program. Here, the other part of the work ahead shall be discussed, that is, the focus is on regulatory implementation once the technological challenges are managed, but we are well aware that the technical aspects of what the National Academy of Science report suggests still need to be addressed: A series of challenges are put forward which we will face in addition to finding a technical solution (and its funding) to set this vision into practice. This includes the standardization and quality assurance of novel methodologies, their formal validation, their integration into test strategies including threshold setting and finally a global acceptance and implementation. This will require intense conceptual steering to have all pieces of the puzzle come together.
美国国家研究委员会于2007年发表的具有里程碑意义的出版物，提出了21世纪毒理学的愿景，这在我们这个领域营造了一种变革的氛围。所形成的联盟、举办的研讨会和会议以及随后发表的文章都意义非凡，表明这是一个时机已到的理念。大部分讨论集中在绘制毒性途径的技术机遇和该项目的资金筹集上。在此，我们将讨论后续工作的另一部分，即一旦技术挑战得到解决，重点将放在监管实施上，但我们清楚地意识到，美国国家科学院报告所建议内容的技术方面仍有待解决：除了找到将这一愿景付诸实践的技术解决方案（及其资金支持）外，我们还将面临一系列挑战。这包括新方法的标准化和质量保证、它们的正式验证、将它们整合到包括阈值设定在内的测试策略中，以及最终的全球认可和实施。这将需要强有力的概念引导，以使所有拼图碎片汇聚在一起。
