目的分析我国上市的药品说明书中群体药动学应用状况，探讨我国药品研发中群体药动学研究的现状。方法在药品说明书数据库软件《新编临床用药参考》中进行关键词检索，并对检索结果进行汇总分析。结果截至2012年3月在《新编临床用药参考》收载的10000余份我国化药制剂与生物制品说明书中检索到18份药品说明书(10个药品通用名品种)包含群体药动学研究资料，这些资料显示了体重、年龄、性别等因素对药物体内过程的影响。结论药品说明书中的群体药动学研究资料体现了该方法在分析变异因素的能力和优势，对于药物剂量的调整有重要意义，但药品说明书中对具体方法和数据类型缺乏具体的描述;检出结果远低于国外研究的数量，我国药品研发中药代动力学研究的水平和生产厂家对药品说明书的重视程度均亟待提高。
关键词
药品说明书 /
群体药动学 /
临床应用
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中图分类号：
R969.1
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参考文献
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