嵌合抗原受体T细胞治疗血液系统肿瘤说明书撰写要求的探讨
Considerations on package inserts for chimeric antigen receptor T cells indicated for hematological malignancy
赵晨阳 1黄云虹 1王晶 1鲁爽1
作者信息
- 1. 国家药品监督管理局 药品审评中心,北京 100076
- 折叠
摘要
我国已有多款嵌合抗原受体T细胞上市,该类产品给血液系统恶性肿瘤患者带来新的治疗选择.与其他药品相比,这类活的细胞产品在临床中的应用具有一定的特殊之处.说明书是承载药品基本信息、安全性、有效性数据等内容的载体,是医务人员和患者合理用药的重要依据.本文主要探讨嵌合抗原受体T细胞说明书的撰写要求,并进行案例分析,以期为该类产品说明书的撰写提供参考,并增进临床应用中对说明书的理解.
Abstract
A number of chimeric antigen receptor T cells have been marketed in China,which bring new therapeutic options for patients with hematologic tumors.Compared with other drugs,the clinical application of such living cell products has certain special features.Package insert is the carrier of basic information,safety and effectiveness data of drugs,and is an important basis of rationally use for medical personnel and patients.In this paper,we mainly discuss the requirements for writing package inserts of chimeric antigen receptor T cells with cases,in order to provide reference for package inserts and improve the understanding in clinical application.
关键词
嵌合抗原受体T细胞/说明书/临床应用Key words
chimeric antigen receptor T cell/package insert/clinical application引用本文复制引用
出版年
2024
国家科技期刊平台
NSTL
维普
万方数据