Fed Regist. 2006 Apr 13;71(71):19193-4.
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "S8 Immunotoxicity Studies for Human Pharmaceuticals." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides recommendations on nonclinical testing approaches to identify compounds that have the potential to be immunotoxic and guidance on a weight-of-evidence decision making approach for immunotoxicity testing. The guidance is intended to provide recommendations on nonclinical testing for immunotoxicity induced by human pharmaceuticals. The guidance applies to unintended immunosuppression and immunoenhancement, excluding allergenicity or drug-specific autoimmunity.
美国食品药品监督管理局（FDA）宣布发布一份名为《用于人类药品的S8免疫毒性研究》的指南。该指南是在人用药品注册技术要求国际协调会议（ICH）的主持下制定的。该指南提供了关于非临床测试方法的建议，以识别具有免疫毒性潜力的化合物，并提供了关于免疫毒性测试的证据权重决策方法的指导。该指南旨在为人用药品引起的免疫毒性的非临床测试提供建议。该指南适用于意外的免疫抑制和免疫增强，不包括过敏性或药物特异性自身免疫。
