ICH领域专业术语-欧盟GMP附录术语-FDA有关术语

第1页共13页ICH领域专业术语表（质量、安全性）序号英文中文1absorption吸收2acceptabledailyintake可接受的日摄入量3acceleratedtest加速试验4acceptancecriteia认可标准5accuracy准确性6accelerated/stressstabilitystudies加速/强力破坏稳定性研究7actionlimits内控限值8activeingredient活性组分9activemetabolite活性代谢产物10additionaltest附加实验11additions添加剂12adduct加合物13adequateexposure充分暴露14adjuvant佐剂15administrationperiod给药期16adventitiousagents外源性因子17adventitiouscontaminants外来污染物18adventitiousviruses外源病毒19adversereaction不良反应20aerobicmicroorganisms需氧微生物21affinity亲和力22affinitychromatography亲和层析23affinitycolumn亲和柱24agarandbroth琼脂和肉汤25aggregation聚集26alteredgrowth生长改变27ambientcondition自然条件28aminoacidsequence氨基酸顺序29aminoacids氨基酸30aminosugars氨基糖31analyticalmethod分析方法32antibiotics抗生素33antibody抗体34antibodyproductiontests抗体产生试验35antigenicspecificity抗原特异性36applicant申报者37artandethicalstandards技术和伦理标准38assessmentofgenotoxicity遗传毒性评价39attainmentoffullsexualfunction达到性成熟40avidity亲和性41background背景42bacteria细菌43basepairs碱基对第2页共13页44basesetofstrains基本菌株45basesubstitution碱基置换46batches批次47batch-to-batch逐批48between-assayvariation试验间变异49bioburden生长量/生物负荷50biochemicalmethods生化方法51biologicalproducts生物制品52biologicalrelevance生物学意义53bioreactor生物反应器54birth出生55bloodplasmafactors血浆因子56bodyburden机体负担57bodyfluids体液58by-products副产物59C(time)一定剂量、某一时间的浓度60calibrate标化61capillaryelectrophoresis毛细管电泳62carbohydrate碳水化合物63carboxy-terminalaminoacids羧基端氨基酸64carcinogen致癌物质65carcinogenesis致癌性66carcinogenichazard致癌性危害67carrier载体/担体68case-by-case个例69catalysts催化剂70cellbank细胞库71cellbanksystem细胞库系统72cellcultures细胞培养物73cellcultures细胞培养74cellexpansion细胞扩增75cellfusion细胞融合76cellline细胞系77celllines细胞系78cellmetabolites细胞代谢物79cellpooling细胞混合80cellproliferation细胞增植81cellreplicationsystem细胞复制系统82cellsubstrates细胞基质83cellsuspension细胞悬液84cellviability细胞活力85centralnervoussystems中枢神经系统86charcoal活性炭87charge电荷88chromatograms色谱图89chromatographicbehavior色谱行为第3页共13页90chromatographicprocedures色谱方法91chromatographycolumns色谱分离柱92colonysizing集落大小93confidenceinterval置信区间94confidencelimits可信限95consistency一致性96container容器97container/closure容器/闭塞物98container/closureintegritytesting容器/密封完整性试验99contaminants污染物100contentuniformity含量均匀度101continuoustreatment连续接触102controlmethodology控制方法学103controlledreleasedproduct控释制剂104conventionallivevirusvaccines传统的活病毒疫苗105conventionalvaccines传统疫苗106correctionfactor校正因子107correlationcoefficient相关系数108cross-contamination交叉污染109cross-linkingagent交联剂110cross-reactivity交叉反应111cryopreservation冷冻保存112cryoprotectants防冻剂113crystals晶体114culturecomponents培养基成分115culturecondiction培养条件116culturemedia/medium培养基117decisionflowchart/tree判断图118Degradation降解产物119degradation降解120degradationpathway降解途径121degreeofscatter离散程度122delayofparturition分娩延迟123descriptivestatistics描述性统计124detectionlimit检测限度125dissolutiontesting溶出试验126dissolutiontime溶出时间127distribution分布128dosageform剂型129dosedependence剂量依赖关系130doselevel剂量水平131dose-limitingtoxicity剂量限制性毒性132dose-rangingstudies剂量范围研究133dose-related剂量相关134dosingroute给药途径135downstreampurification下游纯化第4页共13页136drugproduct制剂137drugproductcomponents制剂组方138drugsubstances原料药139duration周期140endotoxins内毒素141end-point终点142end-productsterilitytesting最终产品的无菌试验143enhancers增强子144enzyme酶145evaluationoftestresult试验结果评价146exvivo体外147excipient赋形剂148expirationdate/dating失效日期149exposureassessment接触剂量评价150exposurelevel暴露程度151exposureperiod接触期152expressionsystem表达系统153expressionvector表达载体154extended-release延时释放155extentofthevirustest病毒测试的程度156falsenegativeresult假阴性结果157falsepositiveresult假阳性结果158fecundity多产159feed-back反馈160fermentation发酵161fermentationproducts发酵产品162fillvolume装量163filteraids过滤介质164finalmanufacturing最终生产165finishedproduct成品166firstpasstesting一期试验167forceddegradationtesting强制降解试验168formallabeling正式标签169formalstabilitystudies正式的稳定性研究170formulation处方/配方171formulation制剂172freeze-driedproduct冻干产品173freshdissectiontechnique新鲜切片技术174friability脆碎度175functionaldeficits功能性指标176functionaltest功能试验177growthfactors生长因子178growthhormones生长激素179half-life半衰期180hardness硬度181heavymetals重金属第5页共13页182herbalproducts草药183hostcell宿主细胞184hostcellbanks宿主细胞库185hostcellDNA宿主细胞DNA186hostcellproteins宿主细胞蛋白质187humidity湿度188humidity-protectingcontainers防湿容器189immediatecontainer/closure直接接触的容器/密闭物190immediatepack内包装191immediaterelease立即释放192immortalization激活193invitro体外194invitroandinvivoinoculationtests体内和体外接种试验195invitroassay体外检测196invitrocellage体外细胞传代期197invitrolifespan体外生命周期198invitrotest体外试验199invitrotests体外试验200invitro/invivocorrelation体内体外相关性201invivo体内202invivoassays体内检测203invivotest体内试验204inactivatedvaccine灭活疫苗205independenttest独立试验206indicatorcell指示细胞207indicatororganisms指示菌208influenzavirus流感病毒209inhalation吸入210inhalationdosageforms吸入剂型211in-house内部的212in-housecriterea内控标准213initialfiling原始文件214initialsubmission最初申报215initialtext最初文本216inoculation接种217inorganicimpurities无机杂质218inorganicmineral无机矿物质219inorganicsalts无机盐220in-processacceptancecriteia生产过程认可标准221in-processcontrols生产过程中控制222in-processtesting生产过程中检测223intendedeffect预期效果224intendedstorageperiod预期的贮藏期225intentionaldegradation人为降解226interactions相互作用227intermediate中间体第6页共13页228intermediates