Introduction of Drug Re-evaluation in Foreign
Countries and Its Enlightenment to China

亚洲社会药学

Introduction of Drug Re-evaluation in Foreign Countries and Its Enlightenment to China

Liu yue 1,2, Sun Lihua 1*

1.School of business administration, Shenyang Pharmaceutical University, Shenyang 110016, China; 2. Beijing Youcare KeChuang pharmaceutical technology Co., Ltd, Beijing 100176, China

出版日期:2017-03-20 发布日期:2017-05-05

Introduction of Drug Re-evaluation in Foreign Countries and Its Enlightenment to China

Liu yue 1,2, Sun Lihua 1*

1.School of business administration, Shenyang Pharmaceutical University, Shenyang 110016, China; 2. Beijing Youcare KeChuang pharmaceutical technology Co., Ltd, Beijing 100176, China

Online:2017-03-20 Published:2017-05-05
Contact: Sun Lihua, professor, doctorial tutor. Major research area: pharmaceutical benefit and investment management, pharmacoeconomics and medicines policy. Tel:024-23986553, E-mail: slh-3632@163.com.

摘要/Abstract

摘要： Objective To provide reference for relevant authorities in China to improve generic drug evaluation by comparing the background and methods of drug re-evaluation in foreign countries. Methods Comparative analysis method was used. Results and Conclusion Reasonable evaluation methods based on the experiences from foreign drug re-evaluation are put forward. It is suggested that the reference catalogue of pharmaceutical preparations and procurement platform should be established. Meanwhile the application process regulations and other measures should be perfected to better the consistency evaluation of generic drugs in China.

关键词: generic drug, consistency evaluation, reference preparation, dissolution curve, bioequivalence

Abstract: Objective To provide reference for relevant authorities in China to improve generic drug evaluation by comparing the background and methods of drug re-evaluation in foreign countries. Methods Comparative analysis method was used. Results and Conclusion Reasonable evaluation methods based on the experiences from foreign drug re-evaluation are put forward. It is suggested that the reference catalogue of pharmaceutical preparations and procurement platform should be established. Meanwhile the application process regulations and other measures should be perfected to better the consistency evaluation of generic drugs in China.

Key words: generic drug, consistency evaluation, reference preparation, dissolution curve, bioequivalence

Liu yue, Sun Lihua. Introduction of Drug Re-evaluation in Foreign Countries and Its Enlightenment to China [J]. 亚洲社会药学.

Liu yue, Sun Lihua. Introduction of Drug Re-evaluation in Foreign Countries and Its Enlightenment to China [J]. Asina Journal Of Social Pharmacy.

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亚洲社会药学

Introduction of Drug Re-evaluation in Foreign Countries and Its Enlightenment to China

Introduction of Drug Re-evaluation in Foreign Countries and Its Enlightenment to China

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