药学相关词汇大全（PDF77页）

FDA和EDQM术语:CLINICALTRIAL：临床试验ANIMALTRIAL：动物试验ACCELERATEDAPPROVAL：加速批准STANDARDDRUG：标准药物INVESTIGATOR：研究人员；调研人员PREPARINGANDSUBMITTING：起草和申报SUBMISSION：申报；递交BENIFIT（S）：受益RISK（S）：受害DRUGPRODUCT：药物产品DRUGSUBSTANCE：原料药ESTABLISHEDNAME：确定的名称GENERICNAME：非专利名称PROPRIETARYNAME：专有名称；INN（INTERNATIONALNONPROPRIETARYNAME）：国际非专有名称ADVERSEEFFECT：副作用ADVERSEREACTION：不良反应PROTOCOL：方案ARCHIVALCOPY：存档用副本REVIEWCOPY：审查用副本OFFICIALCOMPENDIUM：法定药典（主要指USP、NF）．USP（THEUNITEDSTATESPHARMACOPEIA）：美国药典NF（NATIONALFORMULARY）：（美国）国家处方集OFFICIAL＝PHARMACOPEIAL=COMPENDIAL：药典的；法定的；官方的AGENCY：审理部门（指FDA）IDENTITY：真伪；鉴别；特性STRENGTH：规格；规格含量（每一剂量单位所含有效成分的量）LABELEDAMOUNT：标示量REGULATORYSPECIFICATION：质量管理规格标准（NDA提供）REGULATORYMETHODOLOGY：质量管理方法REGULATORYMETHODSVALIDATION：管理用分析方法的验证COS/CEP欧洲药典符合性认证ICH（InternationalConferenceonHarmonizationofTechnicalRequirementsforRegistrationofPharmaceuticalsforHumanUse)人用药物注册技术要求国际协调会议ICH文件分为质量、安全性、有效性和综合学科4类。质量技术要求文件以Q开头,再以a,b,c,d代表小项:Q1:药品的稳定性Q2:方法学Q3:杂质Q4:药典Q5:生物技术产品质量Q6:标准规格Q7:GMPQ7a:（原料药的优良制造规范指南）药物活性成分的GMP.GMP英语PIC/S的全称为：PharmaceuticalInspectionConvention/PharmaceuticalInspectionCooperationScheme,PIC/S(制药检查草案),药品检查协会(PIC/S),也有人称PIC/S为医药审查会议/合作计划（PIC/S）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Batch/Lot批次BatchNumber/Lot-Number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FDA，FDA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POST-ORPRE-MARKETSURVEILLANCE：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（OVER—THE—COUNTERDRUG）：非处方药GMP文件常见缩写ABPIAssociationoftheBritishPharmaceuticalIndustryADRAdverseDrugReactionAEAdverseEventAIMActiveIngredientManufacturerANDAAbbreviatedNewDrugApplicationANOVAAnalysisofVarianceASM:ActiveSubstanceManufacturerATCAnatomicalTherapeuticChemicalATXAnimalTestExemptionCertificateBANBritishApprovedNameBIRABritishInstituteofRegulatoryAffairsBNFBritishNationalFormularyBPBritishPharmacopoeiaCofACertificateofAnalysisCofSCertificateofSuitabilityCENTREFORDRUGEVALUATION(CDE)CentreforPharmaceuticalAdministration(CPA)CMSConcernedMemberStateCMS每个成员国COSCertificateofSuitabilityCPMPCommitteeforProprietaryMedicinalProductsCRAClinicalResearchAssociateCRFCaseReportFormCROContractResearchOrganisationCTAClinicalTrialApplicationCTCClinicalTrialCertificateCTDCommonTechnicalDocumentCTXClinicalTrialsExemptionDDDDefinedDailyDoseDGCDailyGlobalComparisonDIADrugInformationAssociationDMFDrugMasterFileDrugRegistrationBranch(DR,ProductEvaluation&RegistrationDivision,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)IBInvestigatorsBrochureICHInternationalConferenceforHarmonisationIDMCIndependentData-MonitoringCommitteeIECIndependentEthicsCommitteeINDInvestigationalNewDrugINNInternationalNon-proprietaryNameInternationalConferenceonHarmonisation(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SPC/SmPCSummaryofProductCharacteristicssummaryofproductcharacteristics(SPC)TherapeuticGoodsAdministration(TGA)USPUSPharmacopoe