生物技术药物开展非临床安全药理学评价的考虑

Consideration of non-clinical safety pharmacology evaluation of biopharmaceutics

生物技术药物开展非临床安全药理学评价是非临床评价的重要组成部分。本文系统梳理了生物技术药物安全药理学研究的相关技术要求和评价策略,回顾了部分已批准上市生物技术药物采用的安全药理学研究案例及策略;结合审评工作实践,对生物技术药物伴随开展安全药理学研究存在的问题及原因进行了分析,并对开展相关试验研究的关键考虑点进行了梳理总结,以期为相关工作提供参考。

Objective Non clinical safety pharmacology evaluation of biotechnology-derived pharmaceuticals or biopharmaceuticals(BPs) is an important part of non-clinical evaluation of drugs. This paper systematically combs the relevant technical requirements and evaluation strategies for the safety pharmacology research of biotechnological drugs, and reviews the safety pharmacology research cases and strategies adopted by some approved biotechnological drugs. Combined with the review practice, the problems and reasons of safety pharmacology research of biotechnological drugs were analyzed, and the key considerations of relevant experimental research were summarized, with a view to providing reference for relevant work.