| 对提高人体生物等效性试验安全性策略的探讨 |
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| 引用本文： | 强桂芬,杨漫,张娅喃,王月华,杜冠华,刘会臣. 对提高人体生物等效性试验安全性策略的探讨[J]. 中国新药杂志, 2011, 0(14) |
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| 作者姓名： | 强桂芬 杨漫 张娅喃 王月华 杜冠华 刘会臣 |
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| 作者单位： | 航天中心医院临床药理室;中国医学科学院药物研究所; |
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| 基金项目： | 卫生部公益性行业科研专项(200902008) |
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| 摘 要： | 人体生物等效性试验虽然相对简单,但安全性却不容忽视。结合美国食品药品监督管理局(FDA)对仿制药单品种生物等效性(bioequivalence,BE)试验的研究指南,我们在完成多项仿制药人体生物等效性试验的过程中,在保护受试者安全方面总结了一些经验和体会。针对特殊药物,充分考虑到药物的药理活性可能给受试者带来的安全性问题,科学审慎地从试验方案设计、试验用药、受试者筛选、临床监护到生物样品采集等诸多环节均将受试者的安全和权益考虑在内,尽可能降低受试者的风险,保护受试者安全。文章旨在通过对人体生物等效性试验中安全性策略的探讨,为我国人体生物等效性试验的规范设计操作和提高安全性提供一些建设性意见。
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| 关 键 词： | 生物等效性试验 仿制药 安全性 |
The Discussion on strategy improving the safety in human bioequivalence study |
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| QIANG Gui-fen,YANG Man,ZHANG Ya-nan,WANG Yue-hua,DU Guan-hua,LIU Hui-chen. The Discussion on strategy improving the safety in human bioequivalence study[J]. Chinese Journal of New Drugs, 2011, 0(14) |
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| Authors: | QIANG Gui-fen YANG Man ZHANG Ya-nan WANG Yue-hua DU Guan-hua LIU Hui-chen |
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| Affiliation: | QIANG Gui-fen1,YANG Man1,ZHANG Ya-nan1,WANG Yue-hua2,DU Guan-hua2,LIU Hui-chen1(1 Clinical Pharmacology Department of Aerospace Center Hospital,Beijing 100049,China,2 Institute of Materia Medica,Chinese Academy of Medical Sciences,Beijing 100050,China) |
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| Abstract: | The human bioequivalence(BE) study is simple,but the safety of study should not be ignored.Referring to the guideline on BE study of generic drugs issued by FDA,we summarized a series of experiences concerning subjects' safety based on a number of BE studies we finished.For the special drugs that may influence safety of subjects,we should deliberately take the safety and rights of subjects into considerations from clinical trial design,investigational products,subject screening,and clinical monitoring to th... |
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| Keywords: | bioequivalence study generic drug safety |
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