高变异药物的生物等效性研究进展  

Progress in bioequivalence study of highly variable drugs

作　　者：刘东阳[1] 李丽[1] 江骥[1] 胡蓓[1] 

机构地区：[1]中国医学科学院、中国协和医科大学北京协和医院临床药理中心,北京100730

出　　处：《中国临床药理学杂志》2008年第4期339-343,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：高变异药物的生物等效性研究困扰着众多药学工作者。为此本文阐述了高变异药物等效性研究的难点,并总结了目前对高变异药物进行生物等效性研究的可行性方法:对Cmax进行特殊处理;合理界定生物等效;更改试验设计;更改统计方法;更改均值生物等效性方法的接受标准;在稳态下,研究药物及其生物代谢产物的生物等效性。本文比较了这些方法各自的优缺点,希望能对高变异药物的生物等效性研究起到启发作用。More and more pharmaceutical scientists were confused with the bioequivalence studies of highly variable drugs and products. The question was discussed by FDA, EMEA, et al. The difficulties of bioequivalence studies for highly variable drugs and products were set forth in the article. At the same time, the all solutions were discussed in this review. It include： to deal with Cmax in a special method, to allege bioequivalence in certain circumstances, to optimize trial design, to optimize statistic method, to optimize the bioequivalenee limit in average bioequivalence method and to study bioequivalence in steady - status or study bioequivalence for metabolites not for parent. The advantages and disadvantages of these methods were described and compared with each in this article, it may be useful for the bioequivalence study of highly variable drugs and products.

关 键 词：高变异药物 生物等效性 

分 类 号：R969.1[医药卫生—药理学]