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1、FDAGlossary:GCP，GLP，TRIALAccuracy??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
2、Analysissets??統(tǒng)計(jì)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ATR??衰減全反射法AUCss??穩(wěn)態(tài)血藥濃度－時(shí)間曲線下面積Audit??稽查Auditorinspection??稽查／視察Auditreport??稽查報(bào)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Blindre
3、view??盲態(tài)檢查Blindingmethod??盲法Blinding/masking??盲法，設(shè)盲Block??分段Block??層Blocksize??每段的長度BUN??尿素氮Carryovereffect??延滯效應(yīng)Casehistory??病歷Casereportform??病例報(bào)告表Casereportform/caserecordform,CRF??病例報(bào)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Clinicalequivale
4、nce??臨床等效應(yīng)Clinicalstudy??臨床研究Clinicalstudyreport??臨床試驗(yàn)的總結(jié)報(bào)告Clinicaltrial??臨床試驗(yàn)Clinicaltrialapplication,CTA??臨床試驗(yàn)申請Clinicaltrialexemption,CTX??臨床試驗(yàn)免責(zé)Clinicaltrialprotocol,CTP??臨床試驗(yàn)方案Clinicaltrial/studyreport??臨床試驗(yàn)報(bào)告Cmax??峰濃度Co-investigator??合作研究者Comparison??對照C
5、ompliance??依從性Compositevariable??復(fù)合變量Computer-assistedtrialdesign,CATD??計(jì)算機(jī)輔助試驗(yàn)設(shè)計(jì)Confidenceinterval??可信區(qū)間Confidencelevel??置信水平Consistencytest??一致性檢驗(yàn)Contractresearchorganization,CRO??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(huì)Cr
6、ea??肌酐CRF(casereportform)??病例報(bào)告表Crossoverdesign??交叉設(shè)計(jì)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(jì)分析DF??波動(dòng)系統(tǒng)Dichotomies??二分類Diviation??偏差Documentation??記錄／文件Dose-reactionrelation??劑量－反應(yīng)關(guān)系Doublebli
7、nding??雙盲Doubledummy??雙模擬Doubledummytechnique??雙盲雙模擬技術(shù)Double-blinding??雙盲Dropout??脫落DSC??差示掃描熱量計(jì)Effectiveness??療效Electronicdatacapture,EDC??電子數(shù)據(jù)采集系統(tǒng)Electronicdataprocessing,EDP??電子數(shù)據(jù)處理系統(tǒng)Emergencyenvelope??應(yīng)急信件Endpoint??終點(diǎn)Endpointcriteria/measurement??終點(diǎn)指標(biāo)Equiv
8、alence??等效性Essentialdocumentation??必須文件Ethicscommittee??倫理委員會(huì)Excellent??顯效Exclusioncriteria??排除標(biāo)準(zhǔn)Factorialdesign??析因設(shè)計(jì)Failure??無效，失敗Finalpoint??終點(diǎn)Fixed-doseprocedure??固定劑量法Forcedti
