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| 中药上市后人体群体药代动力学试验设计要点 | |
| 引用本文： | 王建农,姜俊杰,谢雁鸣. 中药上市后人体群体药代动力学试验设计要点[J]. 中国中药杂志, 2011, 36(20): 2871-2873 |
| 作者姓名： | 王建农 姜俊杰 谢雁鸣 |
| 作者单位： | 1. 中国中医科学院西苑医院,北京,100091 2. 中国中医科学院中医临床基础医学研究所,北京,100700 |
| 基金项目： | 国家"重大新药创制"科技重大专项(2009ZX09502-030);中国中医科学院自主选题研究项目(Z0133) |
| 摘 要： | 中药人体群体药代动力学(population pharmacokinetics,PPK)是定量考察患者群体中药物浓度决定因素的一门学科.进行合理的中药PPK试验设计可为临床用药提供真实客观的数据,进而促进临床个体化用药方案的制订.该文参考历年文献,并结合实际工作经验,针对中药人体PPK试验设计的要点进行总结,主要包括研究对象的选择、指标的选取、样本采集方案设计、血液样本分析方案设计、数据分析方案设计. |
| 关 键 词： | 中药人体群体药代动力学 试验设计 |
| 收稿时间： | 2011-08-06 |
Key elements of design about PPK of Chinese medicine after marketing |
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| WANG Jiannong,JIANG Junjie and XIE Yanming. Key elements of design about PPK of Chinese medicine after marketing[J]. China Journal of Chinese Materia Medica, 2011, 36(20): 2871-2873 | |
| Authors: | WANG Jiannong JIANG Junjie XIE Yanming |
| Affiliation: | Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China;Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China;Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China |
| Abstract: | PPK is a discipline that quantitative investigates the determinants of drug concentration in patient groups. Developing reasonable PPK design of experiment can provides the real objective data for clinical medicationand then promotes the formulating of clinical individualized medication regimens. This paper referenced over all years literatures, and combined with practical work experience. Summarizes of the main points of PPK design of experiment focused on traditional Chinese medicine. The content mainly included choosing research objects, selecting items,designing sample collection steps,blood sample analysis experiments and data analysis schemes. |
| Keywords: | population pharmacokinetics of Chinese medicine design of experiment |
| 本文献已被 CNKI 万方数据 PubMed 等数据库收录！ | |