摘要
《中国药典》2020年版三部“生物制品生物活性/效价测定方法验证指导原则”(通则9401)是国内首个适用于生物制品生物活性/效价测定方法验证的指导原则,弥补了国内缺少针对生物活性方法验证指导原则的空白。为正确理解和执行该指导原则,推动国内生物活性/效价测定方法验证工作的规范化,本文从该指导原则的新增背景、起草过程、国内外药典比较和主要内容解读等几方面进行了阐述,并对未来该通则内容的完善进行了初步展望,旨在为广大从业人员提供指导性建议及参考。
Guidelines for verification of bioassay/potency test determination methods of biological products(general chapter 9401)in the Chinese Pharmacopoeia 2020 volumeⅢare the first guidelines applicable to verification of bioassay/potency test determination methods of biological products in China.which makes up for the lack of guidelines for verification of bioactivity methods in China.In order to properly understand and carry out<9401>Bioassay/Potency Test of biological products in 2020 of the Chinese Pharmacopeia,here introduce the revised background,process of drafting,comparisons with international standard,and explain the main content,as well as look forward to perfecting the guideline,for the purpose of providing guidance,recommendations and references for biological products industry personnel.
作者
王鸣人
陈钢
赵宇豪
邵泓
段徐华
WANG Mingren;CHEN Gang;ZHAO Yuhao;SHAO Hong;DUAN Xuhua(NMPA Key Laboratory for Quality Control of Therapeutic Monoclonal Antibodies,Shanghai Institute for Food and Drug Control,Shanghai 201203,China)
出处
《中国药品标准》
CAS
2022年第3期241-245,共5页
Drug Standards of China
基金
药品医疗器械审评审批制度改革专项课题《生物制品生物活性/效价测定方法验证指导原则(通则)》(课题编号:ZG2018-3-04)
上海市研发公共服务平台项目(19DZ2294600)。
