| 生化药物生物活性测定方法及其替代方法研究 |
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| 引用本文： | 李震,张媛,高华.生化药物生物活性测定方法及其替代方法研究[J].科技导报(北京),2017,35(13):66-69. |
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| 作者姓名： | 李震 张媛 高华 |
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| 作者单位： | 中国食品药品检定研究院, 北京 100050 |
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| 基金项目： | 2015年国家药品标准提高项目；“重大新药创制”科技重大专项（2015ZX09303-001） |
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| 摘 要： | 通过比较中国和国外药典对于部分生化药物的生物活性测定方法的不同，分析了中国理化方法替代生物活性测定方法的趋势。针对生化药物活性组分的不同对其进行分类并分别提出了理化替代方法建立与验证的思路，总结了替代研究时的实验设计思路与实验结果的统计分析方法，探讨了不同质量控制模式之间的关系，对中国质量控制方法的发展提出了展望。
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| 关 键 词： | 生化药物 生物活性测定法 理化方法 替代 |
| 收稿时间： | 2016-08-30 |
Bioassays of biochemical drugs and their alternatives |
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| LI Zhen,ZHANG Yuan,GAO Hua.Bioassays of biochemical drugs and their alternatives[J].Science & Technology Review,2017,35(13):66-69. |
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| Authors: | LI Zhen ZHANG Yuan GAO Hua |
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| Institution: | National Institutes for Food and Drug Control, Beijing 100050, China |
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| Abstract: | An overview of the definition, the strengths and the limitations of bioassays in the quality control is made and the trend of their replacement by physical and chemical methods through a comparison of ChP and other countries’pharmacopeia is analyzed. Ideas and references of the establishment and the validation of the alternative methods are provided for different sorts of biochemical drugs. The review also summarizes the most common experimental design and two statistical analysis methods. At last, the importance of the combination and the promotion of different quality control modes is emphasized. |
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| Keywords: | biochemical drugs bioassays physical and chemical methods alternative research |
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