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

VernacularTitle:重组人促卵泡激素药物非临床评价的思考
Author: Mei-Ling CHEN ¹ ; Zeng-Ping XU ; Lan CUI ; Ping CAO ; Shuang WU ; Xiao-Dong ZHANG
Author Information

1. 国家药品监督管理局药品审评中心,北京 100022
Keywords: recombinant human follicle stimulating hormone; non-clinical evaluation; drug development; clinical development prospect
From: The Chinese Journal of Clinical Pharmacology 2024;40(9):1385-1392
CountryChina
Language:Chinese
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.