摘要
2006年以来,FDA,EMA和ICH陆续颁布了针对幼龄动物研究的指导原则。与其他指导原则不同,这些指导原则并未对动物研究设计提出具体要求,但是明确儿科用药非临床安全性评价试验方案是基于逐案原则,需要根据患病人群特点、药理学作用、已有的毒性资料、临床数据、给药方案以及影响到的发育系统等进行设计。通常采用以下3种的设计方案之一:1一般毒性筛选研究设计。2围产期发育毒性结合幼龄毒性的研究设计。3靶器官发育毒性研究设计。结合本实验室的经验,本文着重讨论幼龄动物非临床发育毒性的研究设计的策略,以期为我国儿童用药物非临床安全性研究提供支持和参考,为制定我国相关的指导原则积累经验。
The FDA,EMA and ICH guidelines issued for juvenile animal testing since 2006. Unlike other regulatory guidance,the need or design of these animal studies is not specified. However,non-clinical safety evaluation of paediatric medicines should be decided as ‘case-by-case＇. Study design should be based on the patient population,pharmacology,existing toxicological and clinical data,dosing regimen,and developing system impact. Juveniletoxicity studies are generally conducted using one of three designs： 1 general toxicity screening study design;2 combined pre-and postnatal development and juvenile toxicity study design; 3 targeted development toxicity study design. Combined with the experience of our laboratory,the paper focuses on the strategy of study design for juvenile non-clinical developmental toxicity. We wish to provide a supporting reference to non-clinical safety evaluation of pediatric medicine,to develop the guiding principle,and to accumulate experience in China.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2016年第21期2473-2482,共10页
Chinese Journal of New Drugs
基金
上海市实验动物创新行动计划项目(14140901302)
上海市男性生殖与泌尿疾病药物非临床评价专业技术服务平台(15DZ2290400)
关键词
幼龄动物
儿科用药
非临床安全性评价
实验设计
juvenile animal
pediatric medicines
non-clinical safety evaluation
study design
