1题目基于药品生产质量控制视角下的仿制药一致性评价探讨目录摘要............................................................................................................................................2Abstract........................................................................................................................................21绪论........................................................................................................................31.1研究背景.........................................................................................................31.2研究内容.........................................................................................................31.3研究意义.........................................................................................................31.4文献综述.........................................................................................................42仿制药一致性的国内外情况...................................................................................53制药企业质量过程控制...........................................................................................53.1质量控制的制约因素.....................................................................................53.1.1参比制剂的选择.....................................................................................63.1.2原辅料的质量控制.................................................................................73.1.3溶出曲线的借鉴.....................................................................................83.2QBD理念的运用及其作用.............................................................................93.3日本企业仿制药再评价工程对我国制药企业的启示................................94药物经济学角度下的仿制药发展..........................................................................105总结与展望...............................................................................................................11参考文献2致谢基于药品生产质量控制视角下的仿制药一致性评价探讨摘要：本文使用了中国知网数据库，查找了关于我国仿制药一致性评价的相关文献，并对检索出的324篇文献进行分析，分析角度包括国内外仿制药一致性评价的发展历程与成果；生产过程仿制药质量的重要控制因素分析，QBD理念的运用，日本仿制药改革的经验，药物经济学视角下的仿制药发展。通过研究分析我国在仿制药一致性评价过程中可以从哪些方面进行突破改革，以提高仿制药一致性评价的质量。关键字：仿制药；一致性评价；质量控制；生产StudyonproductionqualityofgenericdrugconsistencyevaluationAbstract:Inthispaper,theChineseknowledgenetworkdatabaseisusedtofindtherelevantliteratureabouttheconsistencyevaluationofChinesegenericdrugs,andtoanalyzethe324documentsretrieved.Theanalysisangleincludesthedevelopmentprocessandresultsoftheconsistencyevaluationofthegenericdrugsathomeandabroad,theimportantcontrolfactoranalysisofthequalityofthegenericdrugsinthe3productionprocess,andthetransportationoftheQBDconcept.Japan'sexperienceingenericdrugreform,theimpactofCROandtestcenterongenericdrugs.Throughresearchandanalysis,wecanmakebreakthroughreformsintheprocessofgenericdrugconsistencyevaluationinordertoimprovethequalityofgenericdrugconsistencyevaluation.Keywords：genericdrug；Consistencyevaluation；QualityControl；Production1绪论1.1研究背景我国目前已经是世界第二大医药市场，我国批准上市的药品1.6万个。拥有大约17万...
