German Federal Institute for Risk Assessment (BfR), Center for Alternative Methods to Animal Experiments (ZEBET), Berlin, Germany.
Environ Health Perspect. 2012 Nov;120(11):1489-94. doi: 10.1289/ehp.1104782. Epub 2012 Aug 7.
In biomedical research, the past two decades have seen the advent of in vitro model systems based on stem cells, humanized cell lines, and engineered organotypic tissues, as well as numerous cellular assays based on primarily established tumor-derived cell lines and their genetically modified derivatives.
There are high hopes that these systems might replace the need for animal testing in regulatory toxicology. However, despite increasing pressure in recent years to reduce animal testing, regulators are still reluctant to adopt in vitro approaches on a large scale. It thus seems appropriate to consider how we could realistically perform regulatory toxicity testing using in vitro assays only.
Here, we suggest an in vitro-only approach for regulatory testing that will benefit consumers, industry, and regulators alike.
在生物医学研究中，过去二十年见证了基于干细胞、人源化细胞系和工程化器官样组织的体外模型系统的出现，以及基于主要建立的肿瘤衍生细胞系及其遗传修饰衍生物的众多细胞检测方法。
人们高度期望这些系统可能取代监管毒理学中对动物试验的需求。然而，尽管近年来越来越大的压力要求减少动物试验，但监管机构仍然不愿意大规模采用体外方法。因此，考虑如何仅使用体外检测方法进行监管毒性测试似乎是合适的。
在这里，我们提出了一种仅用于监管测试的体外方法，这将使消费者、行业和监管机构受益。
