首页|重组人促卵泡激素药物非临床评价的思考

重组人促卵泡激素药物非临床评价的思考

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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.
Consideration on non-clinical evaluation of recombinant human follicle-stimulating hormone drugs
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.

recombinant human follicle stimulating hormonenon-clinical evaluationdrug developmentclinical development prospect

陈美灵、许曾平、崔岚、曹萍、吴爽、张晓东

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国家药品监督管理局药品审评中心,北京 100022

重组人促卵泡激素 非临床评价 药物研发 临床开发前景

2024

中国临床药理学杂志
中国药学会

中国临床药理学杂志

CSTPCD北大核心
影响因子:1.91
ISSN:1001-6821
年,卷(期):2024.40(9)
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