ICH药品注册的国际技术要求（中文版）Q1Estabilitydata

《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).......