重组人促卵泡激素药物非临床评价的思考
Consideration on non-clinical evaluation of recombinant human follicle-stimulating hormone drugs
陈美灵 1许曾平 1崔岚 1曹萍 1吴爽 1张晓东1
作者信息
- 1. 国家药品监督管理局药品审评中心,北京 100022
- 折叠
摘要
本文综述了重组人促卵泡激素(rFSH)药物的国内外研究进展情况,根据国内外相关指导原则及相关审评案例从审评角度梳理了 rFSH药物非临床评价一般要求和常见问题,并对近年来的研发热点长效rFSH产品的临床开发前景进行分析并给出了相应的建议,以期为相关工作提供参考.
Abstract
This article summarizes the domestic and international research progress of recombinant human follicle stimulating hormone(rFSH).According to relevant guidelines and application cases,the general requirements and common problems for non-clinical evaluation of rFSH are summarized.The clinical development prospects of long-acting rFSH products which is a hot research topic in recent years are analyzed and corresponding suggestions are given in order to provide reference for related work.
关键词
重组人促卵泡激素/非临床评价/药物研发/临床开发前景Key words
recombinant human follicle stimulating hormone/non-clinical evaluation/drug development/clinical development prospect引用本文复制引用
出版年
2024
国家科技期刊平台
NSTL
万方数据