低分子量肝素类仿制药药学研究与评价的基本考虑  

Basic considerations for pharmaceutical research and evaluation of generic low molecular weight heparins

作　　者：赵娜 石靖 许真玉 米贤伟 陈思 曹麒麟 ZHAO Na;SHI Jing;XU Zhenyu;MI Xianwei;CHEN Si;CAO Qilin(Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100076

出　　处：《药学研究》2025年第4期354-358,共5页Journal of Pharmaceutical Research

基　　金：药品监管科学全国重点实验室课题(No.2023SKLDRS0135)。

摘　　要：2024年2月,国家药品监督管理局药品审评中心发布了《低分子量肝素类仿制药药学研究与评价技术指导原则(试行)》。本文结合该指导原则的起草背景,低分子量肝素类产品的主要特点,重点分析并讨论了该类仿制药药学研究和评价的难点和关注点,明确了药学研究和评价的技术要求。旨在建立完善系统的体外药学研究和评价体系,为这类复杂产品的一致性评价研究提供更多的技术支持,促进仿制药高质量发展。In February 2024,CDE of NMPA issued The Guideline of Pharmaceutical Research and Evaluation of Generic Low Molecular Weight Heparins(Trial).This article combines the drafting background of the guideline,the main characteristics of generic low molecular weight heparins,and focuses on analyzing and discussing the difficulties and concerns in pharmaceutical research and evaluation of this type of generic drugs.The technical requirements for pharmaceutical research and evaluation are clarified.The purpose is to establish a comprehensive and systematic in vitro pharmaceutical research and evaluation system,providing more technical support for the consistency evaluation of such complex products and promoting their high-quality development.

关 键 词：低分子量肝素 仿制药 药学研究与评价 

分 类 号：R943[医药卫生—药剂学]