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

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

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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.
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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