| 欧盟制药工业近红外光谱技术应用、申报和变更资料要求指南（草案） |
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| 引用本文： | 乔延江,杜敏,史新元,吴志生,徐冰. 欧盟制药工业近红外光谱技术应用、申报和变更资料要求指南（草案）[J]. 世界科学技术-中医药现代化, 2012, 14(4): 1933-1943 |
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| 作者姓名： | 乔延江 杜敏 史新元 吴志生 徐冰 |
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| 作者单位： | 北京中医药大学中药学院 北京100102 |
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| 基金项目： | 科学技术部国家“十一五”重大新药创制专项（2010ZX09502-002）：清开灵注射液安全性关键技术研究，负责人：乔延江。 |
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| 摘 要： | 本文旨在介绍欧盟制药工业中,近红外光谱法用于定性、定量分析以及过程监控时方法校正、验证和维护的指导原则,以及申报与变更时所需呈递的资料要求。以期为我国近红外光谱技术在制药领域中的研究与应用提供参考。
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| 关 键 词： | 近红外光谱(NIRS) 过程分析技术(PAT) |
| 收稿时间： | 2012-07-09 |
| 修稿时间： | 2012-08-13 |
Introduction to the "Guideline on the Use of Near-infrared Spectroscopy by Pharmaceutical Industry and Data Requirements for New Submissions and Variations (Draft)" |
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| Qiao Yanjiang,Du Min,Shi Xinyuan,Wu Zhisheng and Xu Bing. Introduction to the "Guideline on the Use of Near-infrared Spectroscopy by Pharmaceutical Industry and Data Requirements for New Submissions and Variations (Draft)"[J]. World Science and Technology—Modernization of Traditional Chinese Medicine and Materia Medica, 2012, 14(4): 1933-1943 |
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| Authors: | Qiao Yanjiang Du Min Shi Xinyuan Wu Zhisheng Xu Bing |
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| Affiliation: | School of Chinese Pharmacy, Beijing University of Chinese Medicine, Beijing 100102, China |
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| Abstract: | This paper was aimed to introduce a draft guideline newly issued by the European Agency for the Evaluation of Medicinal Products (EMEA) which is intended to provide guidance to pharmaceutical industry in the process of calibration, validation and maintenance of a near-infrared spectroscopy (NIRS) method when used for quantitative/qualitative analysis and process monitoring and the type of data requirements for new submissions and variations. |
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| Keywords: | Near-infrared spectroscopy process analytical technology |
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