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时间:2019-05-16
《ICH药品注册的国际技术要求(中文版)Q1Estabilitydata》由会员上传分享,免费在线阅读,更多相关内容在行业资料-天天文库。
1、GuidanceforIndustryQ1EEvaluationofStabilityDataU.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)CenterforBiologicsEvaluationandResearch(CBER)June2004ICHGuidanceforIndustryQ1EEvaluationofStabilityDataAdditiona
2、lcopiesareavailablefrom:OfficeofTrainingandCommunicationDivisionofDrugInformation,HFD-240CenterforDrugEvaluationandResearchFoodandDrugAdministration5600FishersLaneRockville,MD20857(Tel)301-827-4573http://www.fda.gov/cder/guidance/index.htmOfficeofCommunication,T
3、raining,andManufacturersAssistance,HFM-40CenterforBiologicsEvaluationandResearchFoodandDrugAdministration1401RockvillePike,Rockville,MD20852-1448http://www.fda.gov/cber/guidelines.htm.(Tel)VoiceInformationSystemat800-835-4709or301-827-1800U.S.DepartmentofHealtha
4、ndHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)CenterforBiologicsEvaluationandResearch(CBER)June2004ICHTABLEOFCONTENTSI.INTRODUCTION(1.0)............................................................................................
5、............1II.EVALUATIONOFSTABILITYDATA(2.0)..................................................................2A.GeneralPrinciples(2.1).................................................................................................................2B.DataPrese
6、ntation(2.2)..................................................................................................................3C.Extrapolation(2.3)...................................................................................................................
7、......4D.DataEvaluationforRetestPeriodorShelfLifeEstimationforDrugSubstancesorProductsIntendedforRoomTemperatureStorage(2.4)...........................................................................4E.DataEvaluationforRetestPeriodorShelfLifeEstimationforDrugSub
8、stancesorProductsIntendedforStorageBelowRoomTemperature(2.5)...............................................................6F.GeneralStatisticalApproaches(2.6).......
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