摘要
随着生物技术药物研发的增加,具有免疫调节功能的生物技术药物在具有生育潜力人群、儿童和青少年相关疾病治疗中的应用也不断增加,使得这类药物的发育免疫毒性(developmental immunotoxici-ty,DIT)越来越受到人们的关注。由于大分子生物技术药物与小分子化学药物本身存在差异,因此传统的DIT评价方法可能需要在种属选择、实验设计等方面加以改进以适应大分子药物的特点。本文将从种属选择、给药时间、给药剂量、检测终点几方面对生物技术药物的非临床DIT研究进行综述。
The research and development of biopharmaceuticals is increased, and the immunomodulatory biopharmaeeuticals for men and women of child-bearing potential as well as for pediatric and juvenile indications have been developed. Therefore, developmental immunotoxicity （DIT） has gained attention. Differences exist be- tween small molecular drugs and biopharmaeeuticals; therefore, to adapt to the characteristics of large molecular drugs, the traditional DIT evaluation methods require to be improved in species selection, experiment design and so on. This article will review the preclinical DIT research of biopharmaceuticals from the aspects of species selection, time of administration, dosage and evaluation points.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2013年第12期1410-1414,共5页
Chinese Journal of New Drugs
基金
建立符合国际GCP规范的药物非临床安全评价技术平台(2012ZX09302002)
关键词
发育免疫毒性
生物技术药物
免疫调节
非临床
生殖发育毒性
developmental immunotoxicity
biopharmaceuticals
immunomodulatory
nonclinical
devel-opmental and reproductive toxicity
