中国临床药理学杂志2024，Vol.40Issue(3)：472-476,5.DOI:10.13699/j.cnki.1001-6821.2024.03.034
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
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分类
医药卫生引用本文复制引用
赵晨阳,黄云虹,王晶,鲁爽..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[J].中国临床药理学杂志,2024,40(3):472-476,5.
