| IND综合评价的逻辑结构及成药性评价 |
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| 引用本文： | 王庆利. IND综合评价的逻辑结构及成药性评价[J]. 微生物学杂志, 2015, 0(1) |
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| 作者姓名： | 王庆利 |
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| 作者单位： | 国家食品药品监督管理总局药品审评中心，北京 100038 |
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| 摘 要： | 基于各学科信息作出安全性、有效性和质量可控性方面的综合评价是新药研究评价的灵魂，是一个多学科、多组织参与的综合决策过程。根据新药评价研究的实际工作经验，介绍一个新药临床试验综合评价的逻辑性、结构性的工作思考模式，有助于将不同专业的技术信息和技术结论有机整合，作出科学决策。
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| 关 键 词： | 新药临床试验；综合评价；成药性 |
Logical Structure of Comprehensive Evaluation for Investigational New Drug and Druggablity |
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| WANG Qingli. Logical Structure of Comprehensive Evaluation for Investigational New Drug and Druggablity[J]. Journal of Microbiology, 2015, 0(1) |
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| Authors: | WANG Qingli |
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| Affiliation: | Center for Drug Evaluation, China Food and Drug Administration, Beijing 100038, China |
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| Abstract: | Based on each subject information making comprehensive evaluation of safety, efficacy and quality control aspects is the soul of new drug research and evaluation. It is a comprehensive decision-making process of multi-disciplinary and multi-organization participation. According to the working experience of the new drug evaluation research, a logical, structural thinking model for decision-making in investigational new drug (IND) comprehensive evaluation was introduced, which may help to the organic integration of different professional technical information and conclusion, to make a scientific decision. |
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| Keywords: | investigational new drug comprehensive evaluation druggablity |
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