Rispin Amy, Stitzel Katherine, Harbell John, Klausner Mitchell
US Environmental Protection Agency, Office of Pesticide Programs (7506C), Washington, DC, USA.
Regul Toxicol Pharmacol. 2006 Jul;45(2):97-103. doi: 10.1016/j.yrtph.2005.03.005. Epub 2006 Apr 27.
In Vitro toxicology methods are being validated and adopted by regulatory agencies for use as alternatives to animal testing. Such methods may use ex vivo tissues or bioconstructs, some of which may be proprietary. Users of the data from these methods need to be reassured that the assays or assay components used in their studies provide consistent, good quality data over time, matching the standards achieved during the validation process. This paper presents an overview of approaches currently used by representatives of a manufacturer and a contract testing laboratory to ensure that the results from in vitro alternative methods are reproducible and of high quality over time. These approaches include full characterization of cells or tissues, sampling of each lot of manufactured bioconstructs for performance, and regular use of controls and benchmark chemicals to provide assurance of consistency of assay performance.
体外毒理学方法正在得到监管机构的验证并被采用，以替代动物试验。此类方法可能会使用离体组织或生物构建体，其中一些可能是专利产品。使用这些方法所获数据的用户需要得到保证，即其研究中使用的检测方法或检测组件能够长期提供一致、高质量的数据，符合验证过程中所达到的标准。本文概述了一家制造商和一家合同检测实验室的代表目前所采用的方法，以确保体外替代方法的结果具有可重复性且长期保持高质量。这些方法包括对细胞或组织进行全面表征、对每一批生产的生物构建体进行性能抽样，以及定期使用对照品和基准化学品以确保检测性能的一致性。
