| 1991-2010年26个撤市药品分析 |
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| 引用本文： | 冯柳,曹晨,于元元,胡元佳,王一涛.1991-2010年26个撤市药品分析[J].中国药房,2012(33):3158-3159. |
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| 作者姓名： | 冯柳 曹晨 于元元 胡元佳 王一涛 |
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| 作者单位： | 澳门大学中华医药研究院／中药质量控制国家重点实验室,澳门 |
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| 摘 要： | 目的:分析撤市药品,为制药企业保证产品在市场的稳定性提供参考。方法:对由艾美仕市场研究公司及美国FDA1991-2010年公布的26个撤市药品进行治疗类别,药品研发过程中的合作、并购、专利情况,不同时间撤市药品的数量,退市时间与替代药品注册时间的分析。结果与结论:治疗类别对撤市药品的影响并不明显,专利与合作经营已经不再能保证产品在市场的稳定性。严格的药品安全监管体制、副作用小且疗效较好的替代药品是影响药品撤市的主要原因。
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| 关 键 词： | 撤市药品 监管 药品替代 原因分析 |
Analysis of the 26 Kinds of Withdrawal Drug during 1991-2010 |
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| FENG Liu,CAO Chen,YU Yuan-yuan,HU Yuan-jia,WANG Yi-tao.Analysis of the 26 Kinds of Withdrawal Drug during 1991-2010[J].China Pharmacy,2012(33):3158-3159. |
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| Authors: | FENG Liu CAO Chen YU Yuan-yuan HU Yuan-jia WANG Yi-tao |
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| Institution: | (State Key Lab of Quality Control for TCM/Institute for Chinese Medicine Science,The University of Macau,Macau,China) |
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| Abstract: | OBJECTIVE：To analyze withdrawal drugs,and to provide reference for the stability guarantee of product in the market by pharmaceutical manufacturers.METHODS：26 kinds of withdrawal drugs announced in 1991-2010 by IMS Health Inc.and USA FDA were analyzed from therapeutic classification,cooperation,MA and patent situation during the RD process,number of different time,withdrawal time and marketed time of substitutes.RESULTS CONCLUSIONS：Drugs withdrawal is hardly affected by therapeutic areas,and patent and co-operation can no longer guarantee the stability of market.Main reasons for drugs withdrawal are strict supervision system,substitutes with low side effect and high efficiency. |
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| Keywords: | Withdrawal drug Supervision Drug substitution Analysis of reasons |
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