Basic considerations for pharmaceutical research and evaluation of generic low molecular weight heparins
ZHAO Na
SHI Jing
XU Zhenyu
MI Xianwei
CHEN Si
CAO Qilin
Abstract：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 characteris-tics of generic low molecular weight heparins,and focuses on analyzing and discussing the difficulties and concerns in phar-maceutical 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 e-valuation system,providing more technical support for the consistency evaluation of such complex products and promoting their high-quality development.
Keywords：Low molecular weight heparinsGeneric drugPharmaceutical research and evaluation
Publication Date：2025-04-30
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：5( 354-358 )