中国临床药理学杂志2026，Vol.42Issue(4)：590-593,4.DOI:10.13699/j.cnki.1001-6821.2026.04.022
多发性骨髓瘤蛋白酶体抑制剂类化学仿制药药学研究考虑
Considerations for the pharmaceutical research of generic proteasome inhibitors for multiple myeloma
那馨竹 1刘建珍 1章俊麟1
作者信息
- 1. 国家药品监督管理局 药品审评中心,北京 100163
- 折叠
摘要
Abstract
Proteasome inhibitors have become key drugs in the targeted therapy of multiple myeloma in current clinical applications.Based on the publicly available information on the domestic and foreign official websites of drug regulatory authorities regarding currently marketed proteasome inhibitor drugs,such as bortezomib for injection,carfilzomib for injection,and ixazomib citrate capsules,this article proposes the key points of attention in the research of drug substances and drug products for these three agents in pharmaceutical development,in order to promote the marketing of generic drugs.关键词
蛋白酶体抑制剂/原料药/制剂Key words
proteasome inhibitors/drug substances/drug products分类
医药卫生引用本文复制引用
那馨竹,刘建珍,章俊麟..多发性骨髓瘤蛋白酶体抑制剂类化学仿制药药学研究考虑[J].中国临床药理学杂志,2026,42(4):590-593,4.
