Development of the generic drug industry in the US after the Hatch-Waxman Act of 1984

查看全文 作　　者：Garth [1]Boehm;Lixin [1]Yao;Liang [1,2]Han;Qiang [1,3]Zheng

机构地区：[1]Center for Pharmaceutical Information and Engineering Research,College of Engineering,Peking University,Beijing 100871,China;[2]Institute of Molecular Medicine,College of Engineering,Peking University,Beijing 100871,China;[3]Department of Industrial Engineering and Management,College of Engineering,Peking University,Beijing 100871,China

出　　处：《Acta Pharmaceutica Sinica B》索引2013年第3卷第5期,共15页

摘　　要：The key events in the development of the US generic drug industry after the Hatch-Waxman Act of 1984 are systematically reviewed,including the process of approval for generic drugs,bioequivalence issues including“switchability”,bioequivalence for complicated dosage forms,patent extension,generic drug safety,generic substitution and low-cost generics.The backlog in generic review,generic drug user fees,and“quality by design”for generic drugs is also discussed.The evolution of the US generic drug industry after the Hatch-Waxman Act in 1984 has afforded several lessons of great benefit to other countries wishing to establish or re-establish a domestic generic drug industry. 关键词：Generic drugs Drug Price Competition and Patent Term Restoration Act Abbreviated new drug application BIOEQUIVALENCE Drug quality Generic drug substitution

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Development of the generic drug industry in the US after the Hatch-Waxman Act of 1984

参考文献(107)

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