关于甲磺酸伊马替尼口服制剂生物等效性试验设计的几点考虑  

Consideration on the bioequivalence study of imatinib mesylate oral products

作　　者：陈晓媛[1] 杨劲[2] 

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100038 [2]中国药科大学,南京210009

出　　处：《中国临床药理学杂志》2014年第9期840-843,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：人体生物等效性试验是支持仿制药上市的主要临床依据。抗肿瘤药物生物等效性试验有其特殊性,需要结合产品特点、研究目标以及临床可操作性等综合考虑。小分子靶向药物具有与传统细胞毒类药物不同的安全有效性特点,也使得其生物等效性设计有所不同。伊马替尼作为首个上市的小分子酪氨酸激酶抑制剂,其化合物专利已到期成为可仿制产品。本文结合该品种审评中遇到的问题及国外相关指导原则,阐述了当前审评中对伊马替尼人体生物等效性试验设计中一些问题的考虑,期望能为该产品相关研发人员提供参考。Bioequivalence tests are primary clinical evidence for approval of generic drugs. The bioequivalence tests of anti- cancer drug possess particularities,therefore,a combination of product characteristics,clinical research objective,and clinical operability is required to be taken into consideration for design of study protocol. Targeted small molecule drugs are different from conventional cytotoxic drugs on safety and effectiveness,accordingly,making its bioequivalence design distinct from others.Imatinib is the first small molecule tyrosine kinase inhibitor listed,and the compound patent has expired to become generic product. In this paper,problems occurred in the process of drug evaluation and related guidance abroad were reviewed and analyzed,and considerations on bioequivalence test design of imatinib was elaborated,hoping to provide reference for product development personnel.

关 键 词：甲磺酸伊马替尼 生物等效性 抗肿瘤 

分 类 号：R979.1[医药卫生—药品] R954[医药卫生—药学]