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首页 药学专业英语词汇-GMP词汇

药学专业英语词汇-GMP词汇

药学专业英语词汇-GMP词汇

hosii
2009-03-04 0人阅读 举报 0 0 暂无简介

简介:本文档为《药学专业英语词汇-GMP词汇doc》,可适用于考试题库领域

GMP英语PICS的全称为:PharmaceuticalInspectionConventionPharmaceuticalInspectionCooperationScheme,PICS(制药检查草案),药品检查协会(PICS),也有人称PICS为医药审查会议合作计划(PICS)PIC的权威翻译:药品生产检查相互承认公约API(ActivePharmaceuticalIngrediet)原料药又称:活性药物组分AirLock气闸AuthorizedPerson授权人BatchLot批次BatchNumberLotNumber批号BatchNumberingSystem批次编码系统BatchRecords批记录BulkProduct待包装品Calibration校正Cleanarea洁净区Consignmecnt(Delivery)托销药品。FDA(FOODANDDRUGADMINISTRATION):(美国)食品药品管理局IND(INVESTIGATIONALNEWDRUG):临床研究申请(指申报阶段,相对于NDA而言)研究中的新药(指新药开发阶段相对于新药而言即临床前研究结束)NDA(NEWDRUGAPPLICATION):新药申请ANDA(ABBREVIATEDNEWDRUGAPPLICATION):简化新药申请TREATMENTIND:研究中的新药用于治疗ABBREVIATED(NEW)DRUG:简化申请的新药DMF(DRUGMASTERFILE):药物主文件(持有者为谨慎起见而准备的保密资料可以包括一个或多个人用药物在制备、加工、包装和贮存过程中所涉及的设备、生产过程或物品。只有在DMF持有者或授权代表以授权书的形式授权给FDAFDA在审查IND、NDA、ANDA时才能参考其内容)HOLDER:DMF持有者CFR(CODEOFFEDERALREGULATION):(美国)联邦法规PANEL:专家小组BATCHPRODUCTION:批量生产分批生产BATCHPRODUCTIONRECORDS:生产批号记录POSTORPREMARKETSURVEILLANCE:销售前或销售后监督INFORMEDCONSENT:知情同意(患者对治疗或受试者对医疗试验了解后表示同意接受治疗或试验)PRESCRIPTIONDRUG:处方药OTCDRUG(OVERTHECOUNTERDRUG):非处方药GMP文件常见缩写ABPIAssociationoftheBritishPharmaceuticalIndustryADRAdverseDrugReactionAEAdverseEventAIMActiveIngredientManufacturerANDAAbbreviatedNewDrugApplicationANOVAAnalysisofVarianceASM:ActiveSubstanceManufacturerATCAnatomicalTherapeuticChemicalATXAnimalTestExemptionCertificateBANBritishApprovedNameBIRABritishInstituteofRegulatoryAffairsBNFBritishNationalFormularyBPBritishPharmacopoeiaCofACertificateofAnalysisCofSCertificateofSuitabilityCENTREFORDRUGEVALUATION(CDE)CentreforPharmaceuticalAdministration(CPA)CMSConcernedMemberStateCMS每个成员国COSCertificateofSuitabilityCPMPCommitteeforProprietaryMedicinalProductsCRAClinicalResearchAssociateCRFCaseReportFormCROContractResearchOrganisationCTAClinicalTrialApplicationCTCClinicalTrialCertificateCTDCommonTechnicalDocumentCTXClinicalTrialsExemptionDDDDefinedDailyDoseDGCDailyGlobalComparisonDIADrugInformationAssociationDMFDrugMasterFileDrugRegistrationBranch(DR,ProductEvaluationRegistrationDivision,CPAEDQM(EuropeanDirectoratefortheQualityofMedicines)欧洲联盟药品质量指导委员会EEA欧洲经济地区EGMAEuropeanGenericsMedicineAssociationELAEstablishedLicenceApplicationEMEAEuropeanMedicinesEvaluationAgencyEMEA(EuropeanAgencyfortheEvaluationofMedicinalProducts)欧洲联盟药品评价机构EPEuropeanPharmacopoeiaEPAREuropeanPublicAssessmentReportsESRAEuropeanSocietyofRegulatoryAffairsEuropeanPharmacopoeiaCommission欧洲药典委员会FDAFDAFoodandDrugAdministrationfinalevaluationreport(FER)freesalecertificates(FSCs)GCPGoodClinicalPracticeGCP药品临床研究管理规范GLPGoodLaboratoryPracticeGLP药品临床前安全性研究质量管理规范GMPGoodManufacturingPracticeGMP药品生产质量管理规范GSP药品销售管理规范HealthSciencesAuthority(HSA)HSA’sMedicinesAdvisoryCommittee(MAC)IBInvestigatorsBrochureICHInternationalConferenceforHarmonisationIDMCIndependentDataMonitoringCommitteeIECIndependentEthicsCommitteeINDInvestigationalNewDrugINNInternationalNonproprietaryNameInternationalConferenceonHarmonisation(ICH)IPCInProcessControlIRBInstitutionalReviewBoardLICENCEHOLDERMAMarketingAuthorisationMAAMarketingAuthorisationApplicationMAA上市申请MAHMarketingAuthorisationHolderMAH销售许可持有者MCAMedicinesControlAgencyMHWMinistryofHealthandWelfare(Japan)MRMutualRecognitionMRA美国与欧盟的互认协议MRAs(MutualRecognitionAgreements)互相認證同意MRFGMutualRecognitionFacilitationGroupMRPMutualRecognitionProcedureNASNewActiveSubstanceNCENewChemicalEntityNDANewDrugApplicationnewchemicalentities(NCEs)newdrugapplications(NDAs)NSAIDNonSteroidalAntiInflammatoryDrugNTANoticeToApplicantsOOSOutofSpecificationOTCOverTheCounterPAGBProprietaryAssociationofGreatBritainPhEurEuropeanPharmacopoeiaPILPatientInformationLeafletPLProductLicencePOMPrescriptionOnlyMedicinePRODUCTOWNERPSUPeriodicSafetyUpdatesQAQualityAssuranceQCQualityControlRAJRegulatoryAffairsJournalRMSReferenceMemberStateRMS相互认可另一成员国RSDRelativeStandardDeviationRxPrescriptionOnlySAESeriousAdverseEventSMFSiteMasterFileSOPStandardOperatingProcedureSOP(STANDARDOPERATIONPROCEDURE)标准运作程序SPCSmPCSummaryofProductCharacteristicssummaryofproductcharacteristics(SPC)TherapeuticGoodsAdministration(TGA)USPUSPharmacopoeiaVMFVeterinaryMasterFileVPCVeterinaryProductsCommitteeA.A.AAdditionandAmendments增补和修订ACAirConditioner空调器ADRAdverseDrugReaction药物不良反应AFDOAssociationofFoodandDrugOfficials食品与药品官员协会(美国)ACCAccept接受AQLAcceptableQualityLevel合格质量标准ADNAAbbreviatedNewDrugApplication简化的新药申请BOMBillofMaterial物料清单BPCBulkpharmaceuticalChemiclls原料药CBERCenterforBiologicsEvaluationResearch生物制品评价与研究中心CFUColonyFormingUnet菌落形成单位DMFDrugMasterFile药品管理档案CDERCemterforDrugEvaluationamdResearch药物评价与研究中心CICorporateIdentity(Image)企业识别(形象)CIPCleaninginPlace在线清洗CSIConsumerSafetyInsepctor消费者安全调查员CLPCleaningLineProcedure在线清洗程序DALDefectActionLevel缺陷作用水平DEADrugEnforcementAdminestration管制药品管理DSDocumentationSystim文件系统FDAFoodandDrugAdministration食品与药品管理局(美国)GATTGeneralAgreemerntonTariffsandTrade关贸总协会GMPGoodManufacturingPracticeGvp药品生质量管理规范GCPGoodClinicalPractice药品临床实验管理规范GLPGoodLaboratoryPractice实验室管理规范GSPGoodSupplyPractice药品商业质量规范GRPGookRaTAILPractice药品零业质量管理规范GAPGoodAgriculturePractice药材生产管理规范GVPGookValidationPrctice验证管理规范GUPGookUsePractice药品重用规范HVACHeatingVentilationAirConditioning空调净化系统ISOIntematonalOrganizationforStandardization车际标准化组织MOUMemorandumofUnderstanding谅解备忘录PFPorductionFile生产记录用表格OTCOvertheCounter(Drug)非处方药品PLAProductLicenseApplication产品许可申请QAQualityAssurance质量保证QCQualityControl质量控制QMPQualityManagementProcedure质量管理程序SDAStateDrugAdministration国家药品监督管理局SMPStandardManagmertProcedure标准管理程序SOPStandardOperatingProcedure标准操作程序TQCTatalQualityControl全面质量管理USAUnetedStatesPharmacopeia美国药典

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药学专业英语词汇-GMP词汇

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