仿制药上市后生物利用度监测与再评价

强桂芬 韩静 杨漫 张娅喃 王月华 杜冠华 刘会臣

中国药学杂志 ›› 2011, Vol. 46 ›› Issue (16) : 1290-1292.

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中国药学杂志 ›› 2011, Vol. 46 ›› Issue (16) : 1290-1292.
药事管理

仿制药上市后生物利用度监测与再评价

  • 强桂芬1,韩静1,杨漫1,张娅喃1,王月华2,杜冠华2*,刘会臣1*
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摘要

目的 对仿制药上市后生物利用度监测与再评价的必要性进行列举,并就应对策略进行阐述,以供医药学工作者借鉴与参考。方法 对我国仿制药在前期研发、临床试验、生产等诸多方面存在的问题进行分析。结果结论 我国仿制药的质量参差不齐,有必要进行生物利用度的监测与再评价。国家药政部门、药品检验机构、药品生产企业、临床医生、临床药理工作者等应对此引起高度关注,加强药品的自检、抽检、筛查和监督管理,在进行仿制药上市后生物利用度监测与再评价研究的工作中各尽其能,发现存在问题的药物品种,提高我国仿制药研发技术水平。

关键词

仿制药 / 生物利用度 / 监测 / 再评价

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导出引用
强桂芬 韩静 杨漫 张娅喃 王月华 杜冠华 刘会臣. 仿制药上市后生物利用度监测与再评价[J]. 中国药学杂志, 2011, 46(16): 1290-1292

参考文献


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