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[药物研发策略。II. 仿制药]

[Strategies for pharmaceutical research and development. II. Generic drugs].

作者信息

Kuchar M

机构信息

Výzkumný ústav pro farmacii a biochemii, Praha.

出版信息

Ceska Slov Farm. 1996 Jul;45(4):171-6.

PMID:8925240
Abstract

When the patent protection is terminated, the original registered-mark preparation becomes a generic drug, which results in a decrease in its price as compared with the original pharmaceutical. The effects of changes in price relation are discussed from the viewpoint of the generic firms and the manufacturers of original preparations. The differences in the insurance system and legislative regulations of the registration of generic preparations can markedly the size influence of the share of generic drugs in the total consumption of drugs. The future development of generic drugs from a general viewpoint is discussed in relation to the contemporary extensive expiration of patent protection of drugs. The hitherto results are summed up and the topics for the present strategy of the development of generic drugs in the Research Institute for Pharmacy and Biochemistry, or in the Czech Republic, respectively are discussed.

摘要

当专利保护终止时,原来注册的品牌制剂就变成了仿制药,与原研药品相比其价格会降低。从仿制药公司和原研制剂制造商的角度讨论了价格关系变化的影响。仿制药制剂注册的保险制度和立法规定的差异会显著影响仿制药在药品总消费中所占份额的大小。从总体角度讨论了仿制药的未来发展与当代药品专利保护广泛到期的关系。总结了迄今为止的结果,并分别讨论了药学与生物化学研究所或捷克共和国仿制药当前发展战略的主题。

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