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)CurrentStep4versiondated6February2003ThisGuidelineha

2、sbeendevelopedbytheappropriateICHExpertWorkingGroupandhasbeensubjecttoconsultationbytheregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA.技术资料学习必备.....

3、..........ICH指导原则新药物与新产品稳定性研究Q1A（R2）2003.2.6现行第4版Q1A(R2)DocumentHistoryFirstCodificationHistoryDateNewCodificationNovember2005Q1ApprovalbytheSteeringCommitteeunderStep2andreleaseforpublicconsultation.16September1992Q1Q1AApprovalbytheSteeringCommitteeunderS

4、tep4andrecommendationforadoptiontothethreeICHregulatorybodies.Q1wasrenamedQ1A.27October1993Q1AQ1A(R)ApprovalbytheSteeringCommitteeofthefirstrevisionunderStep2andreleaseforpublicconsultation.7October1999Q1A(R1)Q1A(R)ApprovalbytheSteeringCommitteeofthefirstr

5、evisionunderStep4andrecommendationforadoptiontothethreeICHregulatorybodies.8November2000Q1A(R1)CurrentStep4versionQ1A(R2)ApprovalbytheSteeringCommitteeofthesecondrevisiondirectlyunderStep4withoutfurtherpublicconsultation,toincludeconsequencesoftheadoptiono

6、fQ1F(StabilityDataPackageforRegistrationApplicationsinClimaticZonesIIIandIV),andrecommendationforadoptiontothethreeICHregulatorybodies.6February2003Q1A(R2)技术资料学习必备...............CoverNoteforRevisionofQ1A(R)StabilityTestingofNewDrugSubstancesandProducts新药物与

7、新产品稳定性研究Q1A（R）修正说明ThepurposeofthisnoteistooutlinethechangesmadeinQ1A(R)thatresultfromadoptionofICHQ1F“StabilityDataPackageforRegistrationApplicationsinClimaticZonesIIIandIV”.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

8、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-GeneralCase2.2.7.1DrugProduct-StorageCondit