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| 中药上市后再评价的临床定位与若干思考 | |
| 引用本文： | 王昕,苏霞,于杰,谢雁鸣,王永炎.中药上市后再评价的临床定位与若干思考[J].中国中药杂志,2011,36(20):2893-2897. |
| 作者姓名： | 王昕 苏霞 于杰 谢雁鸣 王永炎 |
| 作者单位： | 1. 北京博诺威医药科技发展有限公司,北京100024;中国中医科学院博士后流动站,北京100700 2. 北京博诺威医药科技发展有限公司,北京,100024 3. 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： | 药物上市后再评价是药品研究的一个重要环节,是确保用药安全、有效的手段,也是对新药评价的扩大和延伸.通过系统、规范、严谨的上市后再评价,企业可以全面获得药品上市后的有效性和安全性信息;评价上市后药品的利益和风险;为药品的最佳使用提供科学依据;同时还可为政府卫生决策、企业营销决策和公众健康保障提供及时、科学的技术依据.该文重点讨论中药上市后再评价中临床定位的思考,以及如何通过系统思考与整体计划,达到中药上市后再评价的研究目的. |
| 关 键 词： | 中药 上市后再评价 临床定位 系统思考 整体计划 |
| 收稿时间： | 8/6/2011 12:00:00 AM |
Clinical orientation and thought on several problems in post-marketed reassessment of traditional Chinese medicine |
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| WANG Xin,SU Xi,YU Jie,XIE Yanming and WANG Yongyan.Clinical orientation and thought on several problems in post-marketed reassessment of traditional Chinese medicine[J].China Journal of Chinese Materia Medica,2011,36(20):2893-2897. | |
| Authors: | WANG Xin SU Xi YU Jie XIE Yanming and WANG Yongyan |
| Institution: | Beijing Bionovo Medicine Development Co., Ltd., Beijing 100024, China;Post-doctoral Station of China Academy of Chinese Medical Sciences, Beijing 100700, China;Beijing Bionovo Medicine Development Co., Ltd., Beijing 100024, China;Beijing Bionovo Medicine Development Co., Ltd., Beijing 100024, China;Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medicine, Beijing 100700, China;Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medicine, Beijing 100700, China |
| Abstract: | The post-marketed reassessment is an important link to ensure the safety and effectiveness of traditional chinese medicine.It is also the expansion and stretch of new drug evaluation.Through the systematic, standard, rigorous post-marketed reassessment, the enterprise can full access to drugs after listing the efficacy and safety information, evaluate the interests and risk of the drug and provide the scientific basis for the drug use.It can also provide timely, scientific technology basis for government health decisions, the enterprise marketing decision and public health security.This paper mainly discussed the thought on clinical orientation of traditional chinese medicine in the post-marketed reassessment and how to reach the goal through systematic consideration and overall plan. |
| Keywords: | traditional Chinese medicine post-marketed reassessment clinical orientation systematic consideration overall plan |
| 本文献已被 CNKI 万方数据 PubMed 等数据库收录！ | |