藥物臨床試驗英文縮寫

藥物臨床試驗英文縮寫縮略語英文全稱中文全稱ADEAdverseDrugEvent藥物不良事件ADRAdverseDrugReaction藥物不良反應(yīng)AEAdverseEvent不良事件AIAssistantInvestigator助理研究者BMIBodyMassIndex體質(zhì)指數(shù)CICo-investigator合作研究者COICoordinatingInvestigator協(xié)調(diào)研究者CRCClinicalResearchCoordinator臨床研究協(xié)調(diào)者CRFCaseReportForm病歷報告表CROContractResearchOrganization合同研究組織CSAClinicalStudyApplication臨床研究申請CTAClinicalTrialApplication臨床試驗申請CTXClinicalTrialExemption臨床試驗免責(zé)CTPClinicalTrialProtocol臨床試驗方案

縮略語英文全稱中文全稱CTRClinicalTrialReport臨床試驗報告DSMBDataSafetyandmonitoringBoard數(shù)據(jù)安全及監(jiān)控委員會EDCElectronicDataCapture電子數(shù)據(jù)米集系統(tǒng)EDPElectronicDataProcessing電子數(shù)據(jù)處理系統(tǒng)FDAFoodandDrugAdministration美國食品與藥品管理局FRFinalReport總結(jié)報告GCPGoodClinicalPractice藥物臨床試驗質(zhì)量管理規(guī)范GCPGoodLaboratoryPractice藥物非臨床試驗質(zhì)量管理規(guī)范GMPGoodManufacturingPractice藥品生產(chǎn)質(zhì)量管理規(guī)范IBInvestigator’sBrochure研究者手冊ICInformedConsent知情同意ICFInformedConsentForm知情同意書ICHInternationalConferenceonHarmonization國際協(xié)調(diào)會議IDMIndependentDataMonitoring獨立數(shù)據(jù)監(jiān)察

縮略語英文全稱中文全稱IDMCIndependentDataMonitoringCommittee獨立數(shù)據(jù)監(jiān)察委員會IECIndependentEthicsCommittee獨立倫理委員會INDInvestigationalNewDrug新藥臨床研究IRBInstitutionalReviewBoard機(jī)構(gòu)審查委員會IVDInVitroDiagnostic體外診斷IVRSInteractiveVoiceResponseSystem互動語音應(yīng)答系統(tǒng)MAMarketingApproval/Authorization上市許可證MCAMedicinesControlAgency英國藥品監(jiān)督局MHWMinistryofHealthandWelfare日本衛(wèi)生福利部NDANewDrugApplication新藥申請NECNewDrugEntity新化學(xué)實體NIHNationalInstitutesofHealth國家衛(wèi)生研究所（美國）PIPrincipalInvestigator主要研究者

縮略語英文全稱中文全稱PLProductLicense產(chǎn)品許可證PMAPre-market Approval(Application)上市前許可（申請）PSIStatisticians in thePharmaceuticalIndustry制藥業(yè)統(tǒng)計學(xué)家協(xié)會QAQualityAssurance質(zhì)量保證QCQualityControl質(zhì)量控制RARegulatoryAuthorities監(jiān)督管理部門SASiteAssessment現(xiàn)場評估SAESeriousAdverseEvent嚴(yán)重不良事件SAPStatisticalAnalysisPlan統(tǒng)計分析計劃SARSeriousAdverseReaction嚴(yán)重不良反應(yīng)SDSourceData/Document原始數(shù)據(jù)/文件SDSubjectDiary受試者日記SFDAState Food and DrugAdministration國家食品藥品監(jiān)督管理局

縮略語英文全稱中文全稱SDVSourceDataVerification原始數(shù)據(jù)核準(zhǔn)SELSubjectEnrollmentLog受試者入選表SISub-investigator助理研究者SISponsor-Investigator申辦研究者SICSubjectIdentificationCode受試者識別代碼SOPStandardOperatingProcedure標(biāo)準(zhǔn)操作規(guī)程SPLStudyPersonnelList研究人員名單SSLSubjectScreeningLog受試者篩選表T&RTestandReferenceProduct受試和參比試劑UAEUnexpectedAdverseEvent預(yù)料外不良事件WHOWorldHealthOrganization世界衛(wèi)生組織WHO-ICDRAWHOInternationalConferenceofDrugRegulatoryAuthoritiesWHO國際藥品管理當(dāng)局會議藥物臨床試驗英文縮寫英文全稱中文全稱

英文全稱中文全稱Accuracy準(zhǔn)確度Activecontrol,AC陽性對照活性對照Adversedrugreaction,ADR藥物不良反應(yīng)Adverseevent,AE不良事件Adversemedicalevents不良醫(yī)學(xué)事件Adversereaction藥物不良反應(yīng)Alb白蛋白ALD(ApproximateLethalDose)近似致死劑量ALP堿性磷酸酶Alphaspendingfunction消耗函數(shù)ALT丙氨酸氨基轉(zhuǎn)換酶Analysissets統(tǒng)計分析的數(shù)據(jù)集Approval批準(zhǔn)Assistantinvestigator助理研究者AST天門冬酸氨基轉(zhuǎn)換酶

英文全稱中文全稱ATR衰減全反射法AUCss穩(wěn)態(tài)血藥濃度一時間曲線下面枳Audit稽查Auditorinspection稽查/視察Auditreport稽查報告Auditor稽查員Bias偏性偏倚Bioequivalence生物等效應(yīng)Blankcontrol空白對照Blindcodes編制盲底Blindreview盲態(tài)審核Blindreview盲態(tài)檢查Blindingmethod盲法Blinding/masking盲法/設(shè)盲Block層

英文全稱中文全稱Blocksize每段的長度Carryovereffect延滯效應(yīng)Casehistory病歷Casereportform/caserecordformCRF病例報告表病例記錄表Categoricalvariable分類變量Cav平均濃度CD圓二色譜CL清除率Clinicalequivalence臨床等效應(yīng)Clinicalstudy臨床研究Clinicalstudyreport臨床試驗的總結(jié)報告Clinicaltrial臨床試驗ClinicaltrialapplicationCTA臨床試驗申請ClinicaltrialexemptionCTX臨床試驗免責(zé)

英文全稱中文全稱ClinicaltrialprotocolCTP臨床試驗方案Clinicaltrial/studyreport臨床試驗報告Cmax峰濃度Co-investigator合作研究者Comparison對照Compliance依從性Compositevariable復(fù)合變量Computer-assistedtrialdesignCATD計算機(jī)輔助試驗設(shè)計Confidenceinterval可信區(qū)間Confidencelevel置信水平Consistencytest一致性檢驗ContractresearchorganizationCRO合同研究組織Contract/agreement協(xié)議/合同Controlgroup對照組Coordinatingcommittee協(xié)調(diào)委員會

英文全稱中文全稱Crea肌酐CRF(casereportform)病例報告表Crossoverdesign交叉設(shè)計Cross-overStudy交叉研究Css穩(wěn)濃度Cure痊愈Datamanagement數(shù)據(jù)管理Database建立數(shù)據(jù)庫Descriptivestatisticalanalysis描述性統(tǒng)計分析DF波動系統(tǒng)Dichotomies二分類Diviation偏差Documentation記錄/文件Dose-reactionrelation劑量一反應(yīng)關(guān)系Doubledummy雙模擬

英文全稱中文全稱Doubledummytechnique雙盲雙模擬技術(shù)Dropout脫落DSC差示掃描熱量計Effectiveness療效ElectronicdatacaptureEDC電子數(shù)據(jù)米集系統(tǒng)ElectronicdataprocessingEDP電子數(shù)據(jù)處理系統(tǒng)Emergencyenvelope應(yīng)急信件Endpoint終點—、八、、EndpointCriteria終點指標(biāo)Endpointcriteria/measurement終點指標(biāo)Equivalence等效性EssentialDocumentation必需文件Ethicscommittee倫理委員會Excellent顯效Exclusioncriteria排除標(biāo)準(zhǔn)

英文全稱中文全稱Factorialdesign析因設(shè)計Failure無效失敗Finalpoint終點—、八、、Fixed-doseprocedure固定劑量法Forcedtitration強(qiáng)制滴定Fullanalysisset全分析集GC-FTIR氣相色譜一傅利葉紅外聯(lián)用GC-MS氣相色譜一質(zhì)譜聯(lián)用Genericdrug通用名藥Globalassessmentvariable全局評價變量GLU血糖Goodclinicalpractice,GCP藥物臨床試驗質(zhì)量管理規(guī)范Goodmanufacturepractice,GMP藥品生產(chǎn)質(zhì)量管理規(guī)范Goodnon-clinical laboratorypractice,GLP藥物非臨床研究質(zhì)量管理規(guī)范

英文全稱中文全稱Groupsequentialdesign成組序貫設(shè)計Healtheconomicevaluation,HEV健康經(jīng)濟(jì)學(xué)評價Hypothesistest假設(shè)檢驗Hypothesistesting假設(shè)檢驗Improvement好轉(zhuǎn)InclusionCriteria入選表準(zhǔn)Inclusioncriteria入選標(biāo)準(zhǔn)IndependentethicscommitteeIEC獨立倫理委員會InformationconsentformICF知情同意書InformationGathering信息收集InformedconsentIC知情同意Initialmeeting啟動會議Inspection檢察/視察Institutioninspection機(jī)構(gòu)檢查Institutionreviewboard,IBR機(jī)構(gòu)審查委員會

英文全稱中文全稱Intention-to-treatITT意向性分析（一統(tǒng)計學(xué)）InteractivevoiceresponsesystemIVRS互動式語音應(yīng)答系統(tǒng)Interimanalysis期中分析International Conference of人用藥品注冊技術(shù)要求國際技術(shù)協(xié)調(diào)HarmonizationICH會國際協(xié)調(diào)會議InvestigationalProduct試驗藥物Investigator研究者Investigator’sbrochure,IB研究者手冊Lastobservationcarryforward,LOCF最接近一次觀察的結(jié)轉(zhuǎn)LC-MS液相色譜一質(zhì)譜聯(lián)用LD50板數(shù)致死劑量LOCF,Lastobservationcarryforward最近一次觀察的結(jié)轉(zhuǎn)Logiccheck邏輯檢查

英文全稱中文全稱LOQ(LimitofQuantization)定量限Lostoffollowup失訪Marketingapproval/authorization上市許可證Matchedpair匹配配對Missingvalue缺失值Mixedeffectmodel混合效應(yīng)模式Monitor監(jiān)察員Monitoring監(jiān)查MonitoringPlan監(jiān)察計劃MonitoringReport監(jiān)察報告MRT平均滯留時間MS質(zhì)譜MS-MS質(zhì)譜一質(zhì)譜聯(lián)用MTD(MaximumToleratedDose)最大耐受劑量Multi-centerTrial多中心試驗

英文全稱中文全稱NewchemicalentityNCE新化學(xué)實體NewdrugapplicationNDA新藥申請NMR核磁共振譜Non-clinicalStudy非臨床研究Non-inferiority非劣效性Non-parametricstatistics非參數(shù)統(tǒng)計方法Obedience依從性O(shè)DR旋光光譜Open-label非盲Optionaltitration隨意滴定Originalmedicalrecord原始醫(yī)療記錄Outcome結(jié)果OutcomeAssessment結(jié)果評價Outcomeassessment結(jié)果指標(biāo)評價Outcomemeasurement結(jié)果指標(biāo)

英文全稱中文全稱Outlier離群值Parallelgroupdesign平行組設(shè)計Parameterestimation參數(shù)估計Parametricstatistics參數(shù)統(tǒng)計方法Patientfile病人檔案Patienthistory病歷PerprotocolPP符合方案集Placebo安慰劑Placebocontrol安慰劑對照Polytomies多分類Power檢驗效能Precision精密度Preclinicalstudy臨床前研究Primaryendpoint主要終點―1——、八、、Primaryvariable主要變量

英文全稱中文全稱PrincipleinvestigatorPI主要研究者ProductlicensePL產(chǎn)品許可證Protocol試驗方案ProtocolAmendments修正案QualityassuranceQA質(zhì)量保證QualityassuranceunitQAU質(zhì)量保證部門QualitycontrolQC質(zhì)量控制Querylistqueryform應(yīng)用疑問表Randomization隨機(jī)Rangecheck范圍檢查Ratingscale量表ReferenceProduct參比制劑RegulatoryauthoritiesRA監(jiān)督管理部門Replication可重復(fù)RSD日內(nèi)和日間相對標(biāo)準(zhǔn)差

英文全稱中文全稱Runin準(zhǔn)備期Safetyevaluation安全性評價Safetyset安全性評價的數(shù)據(jù)集Samplesize樣本量樣本大小Scaleoforderedcategoricalratings有序分類指標(biāo)Secondaryvariable次要變量Sequence試驗次序SeriousadverseeventSAE嚴(yán)重不良事件SeriousadversereactionSAR嚴(yán)重不良反應(yīng)Seriousness嚴(yán)重性Severity嚴(yán)重程度Severity嚴(yán)重程度Significantlevel檢驗水準(zhǔn)SimpleRandomization簡單隨機(jī)

英文全稱中文全稱Singleblinding單目Siteaudit試驗機(jī)構(gòu)稽查SOP試驗室的標(biāo)準(zhǔn)操作規(guī)程SourcedataSD原始數(shù)據(jù)SourcedataverificationSDV原始數(shù)據(jù)核準(zhǔn)SourcedocumentSD原始文件Specificity特異性Sponsor申辦者Sponsor-investigator申辦研究者Standardcurve標(biāo)準(zhǔn)曲線StandardoperatingprocedureSOP標(biāo)準(zhǔn)操作規(guī)程Statistic統(tǒng)計量Statisticalanalysisplan統(tǒng)計分析計劃Statisticalmodel統(tǒng)計模型Statisticaltables統(tǒng)計分析表

英文全稱中文全稱Stratified分層StudyAudit研究稽查Studyaudit研究稽查StudySite研究中心Subgroup亞組Sub-investigator助理研究者Subject受試者Subject受試者Subjectdiary受試者日記SubjectEnrollment受試者入選Subjectenrollmentlog受試者入選表SubjectidentificationcodeSIC受試者識別代碼SubjectIdentificationCodeList受試者識別代碼表SubjectRecruitment受試者招募Subjectscreeninglog受試者篩選表

英文全稱中文全稱Superiority檢驗Survivalanalysis生存分析SXRD單晶X-射線衍射Systemaudit系統(tǒng)稽查SystemAudit系統(tǒng)稽查T1/2消除半衰期Targetvariable目標(biāo)變量T-BIL總膽紅素T-CHO總膽固醇TestProduct受試制劑TG熱重分析TLC、HPLC制備色譜Tmax峰時間TP總蛋白Transformation變量變換

英文全稱中文全稱Treatmentgroup試驗組Trialerror試驗誤差TrialInitialMeeting試驗啟動會議TrialMasterFile試驗總檔案Trialobjective試驗?zāi)康腡rialsite試驗場所Tripleblinding三盲Twoone-sidetest雙單側(cè)檢驗Un-blinding揭盲UnexpectedadverseeventUAE預(yù)料外不良事件UV-VIS紫外一可見吸收光譜Variability變異Variable變量Visualanalogyscale直觀類比打分法Visualcheck人工檢查

英文全稱中文全稱Vulnerablesubject弱勢受試者Wash-out洗脫Washoutperiod洗脫期實驗室檢查英文縮寫英文全稱中文全稱血常規(guī)WBCwhitebloodcellcount白細(xì)胞計數(shù)GR%granulocyte中性粒細(xì)胞百分比LY%lymphocyte淋巴細(xì)胞百分比MID%中值細(xì)胞百分比EOS%eosimophil嗜酸性粒細(xì)胞百分比AL%allergylymphocyte變異淋巴細(xì)胞百分比ST%中性桿狀粒細(xì)胞百分比RBCredbloodcell紅細(xì)胞計數(shù)HGBhemoglobin血紅蛋白

英文全稱中文全稱HCThematocrit紅細(xì)胞比積紅細(xì)胞比積MCVmeancorpusularvolume平均紅細(xì)胞體積MCHmeancorpusularhemoglobin平均紅細(xì)胞血紅蛋白含量MCHCmeancorpusularhemoglobinconcerntration平均紅細(xì)胞血紅蛋白濃度RDWredbloodcellvolumedistributionwidth紅細(xì)胞分布寬度變異PLT/BPCplateletcount/bloodplateletcount血小板計數(shù)MPVmeanplateletvolume平均血小板體積PCTplateletocrit血小板比積PDWplateletdistributionwidth血小板分布寬度尿便常規(guī)PHacidity酸堿度NITnitrite亞硝酸鹽GLUglucose尿糖

英文全稱中文全稱SGspecificgravity比重PROprotein尿蛋白BLDblood隱血BILbilirubin尿膽紅素UROurobilinogen尿膽原WBCwhitebloodcell白細(xì)胞addish計數(shù)addishcount艾迪氏計數(shù)/HPhighpowerobjective每高倍視野/LPlowpowerobjective每低倍視野OBoccultbloodtest大便隱血試驗體液常規(guī)CSFcerebrospinal腦積夜Pandypandy龐氏試驗生化檢驗TBtotalbilirubin總膽紅素

英文全稱中文全稱DBdirectbilirubin直接膽紅素TPtotalprotein總蛋白ALBalbumin白蛋白GLOBglobulin球蛋白UREAurea尿素CREAcreatinine肌肝UAuricacid尿酸GLUglucose血糖ALTalanineamiotransferase丙氨酸氨基轉(zhuǎn)移酶ASTaspartateaminotransferase門冬氨酸氨基轉(zhuǎn)移酶GGTY-glutamyltranspeptadase谷氨酰轉(zhuǎn)肽酶CKcreatinekinase肌酸肌酶CK-MBcreatinekinase-MB肌酸肌酶同工酶LDHlactatedehydrogenase乳酸脫氫酶a-HBD a-hydroxybutyrica一羥丁酸脫氫酶

英文全稱中文全稱dehydrogenaseAMYserumamylase血淀粉酶TGtriglyceride肝油三脂CHOLcholesterol膽固醇HDL-chigh-densitylipoproteincholesterol高密度脂蛋白LDL-clow-densitylipoproteincholest