| 在药品申报中关于包装系统研究内容的探讨 |
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| 引用本文： | 马玉楠,霍秀敏,蒋煜.在药品申报中关于包装系统研究内容的探讨[J].中国临床药理学杂志,2012(8):629-632. |
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| 作者姓名： | 马玉楠 霍秀敏 蒋煜 |
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| 作者单位： | 国家食品药品监督管理局药品审评中心 |
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| 摘 要： | 通过分析药品包装系统的作用和我国药用包装材料的管理状况,探讨在药品通用技术文件格式申报中需提供的相关研究内容,及药品研发过程中根据风险程度对包装材料和药品进行相容性研究。
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| 关 键 词： | 药品 包装材料 相容性 通用技术文件 包装系统 |
Discussion on container closure system for drug application |
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| MA Yu-nan,HUO Xiu-min, JIANG Yu.Discussion on container closure system for drug application[J].The Chinese Journal of Clinical Pharmacology,2012(8):629-632. |
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| Authors: | MA Yu-nan HUO Xiu-min JIANG Yu |
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| Institution: | (Center For Drug Evaluation,State Food and Drug Administration,Beijing 100038,China) |
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| Abstract: | To analyze the role of container closure system and the drug packaging materials management in China,this assay discussed the required research contents to be provided in the common technical documents(CTD) format and how to study the compatibility of packaging material and drug products according to different risk levels in the process of drug development. |
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| Keywords: | drug packaging material compatibility common technical documents container closure system |
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