Hastings K L
Division of Special Pathogen and Immunologic Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD 20857, USA.
Toxicol Lett. 1998 Dec 28;102-103:267-70. doi: 10.1016/s0378-4274(98)00319-1.
Evaluating the immunotoxic potential of investigational new drugs is a standard component of non-clinical safety assessment. Effects evaluated include the potential for drugs to induce hypersensitivity and/or autoimmune reactions or to produce unintended immunosuppression. The Center for Drug Evaluation and Research (CDER) is considering approaches for evaluating potential immunotoxicity. In particular, two methods are being examined for potential recommendation where indicated: immune cell phenotype determination and the murine local lymph node assay. Issues concerning immunotoxicology testing will be discussed.
评估新药的免疫毒性潜力是非临床安全性评估的标准组成部分。评估的效应包括药物诱导超敏反应和/或自身免疫反应或产生意外免疫抑制的可能性。药物评价和研究中心（CDER）正在考虑评估潜在免疫毒性的方法。特别是，正在研究两种方法，以便在有指征时进行潜在推荐：免疫细胞表型测定和小鼠局部淋巴结试验。将讨论有关免疫毒理学测试的问题。
