中国临床药理学杂志2024，Vol.40Issue(9)：1385-1392,8.DOI:10.13699/j.cnki.1001-6821.2024.09.031
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
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分类
医药卫生引用本文复制引用
陈美灵,许曾平,崔岚,曹萍,吴爽,张晓东..重组人促卵泡激素药物非临床评价的思考[J].中国临床药理学杂志,2024,40(9):1385-1392,8.
