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内容药品质量控制的四个阶段药品质量-安全有效-生产过程-流通使用的关系图USFDAICHQ8的主要内容药品质量质量源于设计（QbD）与医药质量体系（PQS）之间的关系产品概述药品质量标准认识药品属性与药品质量标准的关系药品质量标准建立的过程Generalizedmethoddevelopmentstrategy(MDS)approachforQbDanalyticalmethods.PlotoflogDversuspH梯度与柱温优化风险评估:鉴别PresentationoftheDesignSpaceforthreefactorsdescribedby2Dplanes.Theworkingpointisinthemiddleofthecubeandrepresentsaresultofthebestcriticalresolution.ThreedifferentresolutionmapsareshownhereasindividualpartsofthewholeDesignSpaceExperimentaldesignforafour-dimensionalHPLCmethodoptimizationWorkflowschemefollowedduringthepresentstudyFourdifferentrunsconstitutingagradienttime–temperature(tG–T)model,showingdifferentselectivitiesandthecorrespondingmatchedpeaktable.tG:30and90min,T:30◦Cand60◦C,pH3.6,100%acetonitrileChromatographicfactorsandresponsevariablesforPlackett–BurmanexperimentaldesignOptimizationmethodparametersforBox–BehnkenexperimentaldesignChromatogramofprotaminesulfateshowingthefourpeptidesResponsesurface(3D)andcontourplotsshowingtheeffectsofpH,flowrateandtemperatureonpeakresolutionandUSPtailingfactorofprotaminesulfatepeaksOverlayoffourpeptidepeaksofprotaminesulfatefromfivedifferentsources中国药典中法莫替丁原料质量标准法莫替丁原料或制剂标准中所采用的有关物质检查方法有关物质检查方法药品质量标准制订的QbD理念初探举例
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