仿制药(Generic Drugs：A generic drug (***，short：generics)isa drug which is produced and distributed without abrand name．A generic drug isidentical，or bioequivalent to a brand name drug indosage form，safety，stren...
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仿制药(Generic Drugs：A generic drug (***，short：generics)isa drug which is produced and distributed without abrand name．A generic drug isidentical，or bioequivalent to a brand name drug indosage form，safety，strength，route of administration，quality，performancecharacteristics and intended use．又名通用名药、学名药、非专利处方药)是相对于原创专利药而言，具有同样活性药成分、剂型、规格和给药途径，并经证明具有相同安全性和治疗等效性。本文介绍了(手性)仿制药的国际发展趋势，分析了国内(手性)仿制药企业现状及对策，阐述了(手性)仿制药物相关规则和专利挑战策略，探讨了国内(手性)仿制药开发专利挑战实践及创新，浅谈了手性药物国家工程研究中心及不对称合成与手性技术。
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