抗肿瘤抗体偶联药物非临床药理毒理研究的考虑要点

发布时间：2019-05-24 07:16

【摘要】：抗肿瘤抗体偶联药物通过靶向释放药物,可降低细胞毒药物的毒性风险,提高治疗指数。抗体偶联药物的组成复杂,与裸单抗和细胞毒药物相比,抗体偶联药物的研发具有更大的挑战。本文基于ICH S6和ICH S9等指导原则,探讨了抗肿瘤抗体偶联药物的非临床药理、安全性以及药动学研究的关注点和考虑。
[Abstract]:Anti-tumor antibody coupling drugs can reduce the risk of cytotoxicity and improve the treatment index by targeted release of drugs. The composition of antibody coupling drugs is complex, and the development of antibody coupling drugs is more challenging than naked monoclonal antibodies and cytotoxicity drugs. Based on the guiding principles of ICH S6 and ICH S9, the non-clinical pharmacology, safety and pharmacokinetics of antitumor antibody coupling drugs were discussed in this paper.
【作者单位】： 国家食品药品监督管理局药品审评中心;
【分类号】：R96
，

本文编号：2484664