q1a(r2)-2003-新原料药与新制剂稳定性设计研究(中英文)

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1、.........................INTERNATIONALCONFERENCEONHARMONISATIONOFTECHNICALREQUIREMENTSFORREGISTRATIONOFPHARMACEUTICALSFORHUMANUSEICHHarmonisedTripartiteGuidelineStabilityTestingofNewDrugSubstancesandProductsQ1A(R2)CurrentStep4versiondated6February2003ThisGuidelinehasbeendevelopedbyth

2、eappropriateICHExpertWorkingGroupandhasbeensubjecttoconsultationbytheregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA.专业资料分享.........................ICH指导原则新药物与新产品稳定性研究Q1A（R2）20

3、03.2.6现行第4版Q1A(R2)DocumentHistoryFirstCodificationHistoryDateNewCodificationNovember2005Q1ApprovalbytheSteeringCommitteeunderStep2andreleaseforpublicconsultation.16September1992Q1Q1AApprovalbytheSteeringCommitteeunderStep4andrecommendationforadoptiontothethreeICHregulatorybodies.Q1wa

4、srenamedQ1A.27October1993Q1AQ1A(R)ApprovalbytheSteeringCommitteeofthefirstrevisionunderStep2andreleaseforpublicconsultation.7October1999Q1A(R1)Q1A(R)ApprovalbytheSteeringCommitteeofthefirstrevisionunderStep4andrecommendationforadoptiontothethreeICHregulatorybodies.8November2000Q1A(R1

5、)CurrentStep4versionQ1A(R2)ApprovalbytheSteeringCommitteeofthesecondrevisiondirectlyunderStep4withoutfurtherpublicconsultation,toincludeconsequencesoftheadoptionofQ1F(StabilityDataPackageforRegistrationApplicationsinClimaticZonesIIIandIV),andrecommendationforadoptiontothethreeICHregu

6、latorybodies.6February2003Q1A(R2)专业资料分享.........................CoverNoteforRevisionofQ1A(R)StabilityTestingofNewDrugSubstancesandProducts新药物与新产品稳定性研究Q1A（R）修正说明ThepurposeofthisnoteistooutlinethechangesmadeinQ1A(R)thatresultfromadoptionofICHQ1F“StabilityDataPackageforRegistrationAppli

7、cationsinClimaticZonesIIIandIV”.Thesechangesare:本注释的目的是概述R1A（R）的变化，这些变化是因采纳了ICHQ1F，即“在气候带III和IV地区注册申请的稳定性研究要求”这一指导原则而产生的，内容包括：1.Theintermediatestorageconditionhasbeenchangedfrom30°C±2°C/60%RH±5%RHto30°C±2°C/65%RH±5%RHinthefollowingsections:2.1.7.1DrugSubstance-StorageConditions-Gener

8、alCase2.2.7.