幼龄动物毒理学试验的案例分析及考虑要点  

Cases Analysis and Considerations on Juvenile Toxicology Studies

作　　者：单晓蕾 黄芳华 姜凯迪 SHAN Xiaolei;HUANG Fanghua;JIANG Kaidi(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国医药工业杂志》2022年第11期1565-1570,共6页Chinese Journal of Pharmaceuticals

摘　　要：近年来儿童用药成为药物开发热点,儿童人群临床试验逐渐增多。当支持开展儿童临床试验安全性的非临床和临床数据缺乏时,需要考虑开展幼龄动物试验,旨在阐述在其他非临床试验或儿童临床试验中无法得到充分阐述的安全性问题,包括潜在的长期安全性的影响。该文基于2020年发布的ICH S11支持儿童用药开发的非临床安全性指导原则并结合实际案例,阐述了幼龄动物试验的设计和实施的考虑要点,以期为我国儿童用药开发提供参考。In recent years,paediatric pharmaceutical has become a hotspot of drug development and clinical trials in paediatric population have gradually increased.The conduct of juvenile animal studies(JAS)should be considered only when previous nonclinical and clinical data are insufficient to support paediatric clinical trials.A JAS is designed to address safety concerns that cannot be adequately addressed in other nonclinical studies or paediatric clinical trials,including potential long-term safety effects.The ICH S11 Nonclinical safety testing in support of development of pediatric pharmaceuticals was issued in 2020.This article discusses considerations of JAS,combining with ICH S11 guidance and cases analysis,aiming to provide information for pediatric pharmaceutical development in China.

关 键 词：ICH S11 幼龄动物试验 儿童用药开发 

分 类 号：R965.3[医药卫生—药理学]