中国临床药理学杂志2025，Vol.41Issue(3)：442-444,3.DOI:10.13699/j.cnki.1001-6821.2025.03.029
替莫唑胺胶囊仿制药药学研发探讨
Pharmeceutical research and development of generic temozolomide capsules
那馨竹 1何艳 1章俊麟 1司晓菲1
作者信息
- 1. 国家药品监督管理局 药品审评中心,北京 100022
- 折叠
摘要
Abstract
Temozolomide capsule is a first-line chemotherapeutic agent for the treatment of glioblastoma and anaplastic astrocytoma.Combined with radiotherapy,it can significantly improve the survival rate of patients,which is of high clinical value.Based on the public information on the websites of National Medical Products Administration,Food and Drug Administration,European Medicines Angecy and Pharmaceuticals and Medical Devices Angecy,the contents of Chineses Pharmacopoeia,United States Pharmacopeia,British Pharmacopeia,and the requirements of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and domestic chemical generic drugs related guidelines,this paper proposed the pharmaceutical research and development concerns of this product,so as to promote the marketing of generic drugs.关键词
替莫唑胺/仿制药/药学研究/体内生物等效性豁免Key words
temozolomide/generic drug/pharmaceutical research/waiver of in vivo bioequivalence study分类
医药卫生引用本文复制引用
那馨竹,何艳,章俊麟,司晓菲..替莫唑胺胶囊仿制药药学研发探讨[J].中国临床药理学杂志,2025,41(3):442-444,3.
