论文部分内容阅读
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。
With the development of biotech drugs, the application of biotechnological drugs with immunomodulatory functions in the treatment of people with fertility potential, children and adolescents has also been increasing, making the developmental immunotoxicity of these drugs (developmental immunotoxicity, DIT) more and more people’s attention. Due to the differences between macromolecular biotech drugs and small molecule chemical drugs, traditional DIT evaluation methods may need to be improved in terms of species selection, experimental design and so on to adapt to the characteristics of macromolecular drugs. This article reviews the nonclinical DIT studies of biotech drugs from the perspectives of species selection, timing of administration, dose administered, and endpoint of testing.