abbreviated or abridged applicat i on简略申请abnormal karyology异常核型absorbed moisture 吸附水acceptable daily intake可接受的日摄入量acceptable test加速试验acceptance criteria认可标准accuracy准确性accelerated/stress stability studies加速/强力破坏稳定性研究acetylation乙酰化作用achiral assay非手性测定achlorhydric elderly老年性胃酸缺乏症action limits内控限值active components/compound/moiety活性成分active ingredient活性组分adaption to specific culture conditions特定培养条件的适应additives添加剂adjuvant佐剂adventitious agents外源性因子adventitious contaminants 外来污染物adventitious viral or mycoplasma contamination外源性病毒或支原体污染adventitious viruses外源病毒adverse reaction不良反应aerobic microorganisms需氧微生物affinity 亲和力affinity chromatography亲和层析affinity column亲和柱agar and broth琼脂和肉汤aggregates聚合体aggregation聚集allergenic/allergic extracts过敏源抽提物altered conjugated forms改变的结合物形式ambient condition自然条件amino acid composition氨基酸组成amino acid sequence氨基酸序列amino acids氨基酸amino sugars氨基糖amino-terminal amino acids 氨基端氨基酸ammonia production Rates产氨率analyte被测物analytical procedure分析方法animal cell lines动物细胞系animal tissues or organs动物组织或器官anternnary profile触角形状antibiotic resistance genes抗生素耐药基因antibiotics抗生素antibody抗体antibody production tests抗体产生实验antisera抗血清applicant申报者ascites腹水assay含量测定assay procedure定量方法avian鸟类avidity亲和性background背景bacteria细菌batches批次batch-to-batch逐批between-assay variation试验间变异binary fission双数分裂binding assays结合试验bioburden生长量/生物负荷biochemical methods生化方法bioequivalency生物等效性biohazard information生物有害信息biological ativity生物活性biological products生物制品bioreactor生物反应器biotechnological/biological products生物技术/生物产品biotechnological products生物技术产品biphasic curve双相曲线blood plasma fators血浆因子body fluids体液bovine牛bovine spongiform encephalopathy(BSE)疯牛病bracketing括号法breeding conditions饲养条件by-prducts副产物calibrate标化canine犬cap liner瓶帽内垫capillary electrophoresis毛细管电泳carbohydrate碳水化合物carboxy-terminal amino acids碳基端氨基酸carrier载体/担体catalysts催化剂cell bank细胞库cell bank system细胞库系统cell banking procedures细胞建库过程cell banking system细胞库系统cell culture-derived impurities来源于细胞培养基的杂质cell cultures细胞培养物cell expansion细胞扩增cell lines细胞系cell metabolites细胞代谢物cell pooling细胞混合cell substrate-derived impurities来源于细胞培养基质的杂质cell substrates细胞基质cell viability细胞活力cell–derived biological products细胞来源的生物制品cell fusion细胞融合cellular blood components血细胞成分cemadsorbing viruses红细胞吸附病毒characterization and testing of cell banks细胞库鉴定及检测charcoal活性炭charge电荷chemical actinometric system化学光化线强度系统chemical reactivity化学反应性chemical syntheses化学合成chemically inert化学惰性chewable tablets咀嚼片chiral impurities手性杂质chromatograms色谱图chromatographic behavior色谱行为chromatographic procedures色谱方法chromatography columns色谱柱circular dichroism圆二色性clearance studies清除研究climatic zones气候带clinical research临床研究clinical trial application临床实验申请cloning克隆closure闭塞物code number编号coding sequence编码序列coefficient of variance变异系数collaborative studies协作实验研究colony isolation菌落分离colony-stimulating factors集落刺激因子combination product复方制剂components成分confidence interval置信区间confidence limits 可信限confirmatory studies确认研究conformance to specifications符合规范conformation构型conjugat ed product连接产物consistency一致性container容器container/closure容器/闭塞物container/closure integrity testing 容器/密封完整性实验contaminants污染物content uniformity含量均匀性control methodology控制方法学controlled released product控制制剂conventional vaccines传统疫苗conventional live virus vaccines传统的活病毒疫苗cool white fluorescent冷白荧光灯correction factor校正因子correlation coefficient相关系数covalent or noncovalent共价或非共价creams霜剂cross-contamination交叉污染cross-reactivity交叉反应cryopreservation冷冻保存cryoprotectants防冻剂crystals晶体culture components培养基成分culture media/medium培养基cyanogens bromide溴化氰cytogenetic细胞遗传学的cytokines细胞因子cytopathic细胞病的cytoplasmic A-and R-type particles细胞浆a型和r型颗粒dark control暗度对照deamidation 去氨基deaminated去酰胺化的decision flow chart/tree判断图definable and measurable biological activity明确和可测定的生物学活性degradant降解产物degradation降解degradation pathway降解途径degradation product降解产物degradation profile降解概况degree of aggregation 凝集程度degree of scatter离散程度delayed –release延迟释放deleterious有害的delivery systems给药体系derivatives衍生物description性状detection limit检测限度dilivery systems释放系统dilution ratio稀释倍数dimmers二聚体diode array二极管阵列diploid cells二倍体细胞dissociation解离dissolution testing 溶出实验dissolution time溶出时间dosage form剂型downstream purification下游纯化drug product制剂drug product components制剂组方drug substances原料药ectromelia virus脱脚病病毒elastomeric closures橡皮塞electron microscopy (EM)电镜electrophoresis电泳electrophoretic pattern电泳图谱elution profile洗脱方案embryonated eggs鸡胚enantiomer对映体enantiomeric对映异构体enantioselective对映体选择性encephalomyocarditis virus(EMC)脑心肌炎病毒endogenous agents内源性因子endogenous retrovirus内源性逆转录病毒endotoxins内毒素end-product sterility testing 最终产品的无菌试验enhancers增强子enveloped RNA viruses包膜RNA病毒environmental factors环境因素enzymatic reaction rates酶反应速率enzyme酶epitope表位Epstein-Barr virus(EBV)EB病毒equine马Erythropoietins促红细胞生成素ethnic origin种族起源eukaryotic cell真核细胞ex vivo体外excipient赋形剂excipient specifications赋形剂规范expiration date/dating 失效日期exposure level暴露程度exposure period光照时间expression constract表达构建体expression system表达系统expression vector表达载体extended-release延时释放extent of the virus test病毒测试程度extinction coefficient消光系数extrachromosomal染色体外extraneous contaminants 外源性污染物exprapolation外推法fermentation发酵fermantation products发酵产物fill volume装量filter aids过滤介质final manufacturing最终生产finished product成品flanking region侧翼区forced degradation testing 强制降解物质foreign matter异质性物质formal labeling 正式标签formal stability studies正式的稳定性研究formulation处方/配方fragmentation片段化freeze-dried product冻干产品friability脆硬度fungi真菌fusion partnters融合伴侣fusion protein融合蛋白gel filtration凝胶过滤gene amplification基因扩增gene therapy基因疗法generation of the cell substance细胞基质的产生genetic manipulation基因操作genomic dinucleotide repeats基因组双核苷酸重复数genomic DNA基因组DNAgenomic polymorphism pattern基因组形态类型glucose consumption rates耗糖率glycoforms糖化形式glycosylation糖基化goegrapgical origin地理起源growth factors生长因子growth hormones生长激素guanidine胍hamster antibody production (HAP) test仓鼠抗体产生实验Hantaan virus汗坦病毒Hardness硬度heavy metals重金属heparins肝素herbal products 草药herpes virus疱疹病毒heterogeneities异质性heterohybrid cell lines异种杂交细胞系high-resolution chromatography高分辨色谱homogeneity均一性host cell宿主细胞host cell banks宿主细胞库host cell DNA宿主细胞DNAhost cell proteins宿主细胞蛋白质hot-stage microscopy热阶显微镜human diploid fibroblasts人二倍体呈纤维细胞human polio virus人脊髓灰质炎病毒human tropism人向性humidity湿度humidity-protecting containers防湿容器hybridization techniques杂交技术hybridoma cell杂交瘤hybridomas水解物hydrolysates水解物hydrolytic enzymes水解酶hydrophobicity疏水性hygroscopic吸湿性idetification/identity鉴别immediate container/closure直接接触的容器/密闭物immediate pack内包装immediate release立即释放immortalization激活immune spleen cells免疫脾细胞immumoassay免疫检测immunochemical methods免疫化学方法immunochemical properties免疫化学性质immunoelectrophoresis免疫电泳immunogenicity免疫原性immunological interations免疫相互作用immunoreactivity免疫反应性impurity profile杂质概况in vitro and in vivo inoculation tests体内和体外接种试验in vitro assay体外检测in vitro cell age体外细胞传代期in vitro lifespan体外生命周期in vitro tests体外试验in vivo 体内in vivo assays体内检测inactivated vaccine灭活疫苗indentification test鉴别试验indicator cell指示细胞indicator organisms指示菌indoor indirect daylight室内间接日光inducers诱导剂infectious agents感染性因子influenza virus流感病毒inhalation dosage forms吸入剂型in-house内部的in-house criteria内控标准in-house primary reference material内部一级参比物质in-house working reference material内部参比物质initial filing原始文件initial submission最初申报initial text最初文件inoculation接种inorganic impurities无机杂质inorganic mineral无机矿物质inorganic salts无机盐in-process acceptance criteia生产过程认可标准in-process controls生产过程中控制in-process testing生产过程中检测insect昆虫insulins胰岛素intake摄入intended effect预期效果intended storage period预期的储藏期intentional degradation人为降解interactions相互作用interferon干扰素interleukins白细胞介素intermediate中间体intermediate precision中间精密度intermediates半成品international reference standards国际参比标准品intra-assay precision间隙含量精密度intracytoplasmic细胞浆内introduction of virus病毒介入inverted or horizontal position倒立或水平位置ion-exchange离子交换ionic content离子含量isoelectric focusing/isoelectrofocusing等电聚焦isoenzyme analysis同工酶分析isoform pattern异构体类型isomerized异构化的Jp /Ph.Eur./Usp.日本药局方/欧洲药典/美国药典K virus K病毒Karyology胞核学laboratory scale实验室规模lactate production rates乳糖产生速率litric deheydrogenase virus(LDM)乳酸脱氢酶病毒leachables沥出物ligand配位体/配体light光照light resistant packaging避光包装limit for in vitro cell age细胞体外传代限度limit of acceptance可接受的限度limit of in vitro cell age体外细胞代次limit test限度试验limulus amoebocyte lysate鲎试剂linear relation ship线性关系linearity线性liquid nitrogen液氮liquid oral dosage forms液体口服制剂live vaccine活疫苗living cells活细胞logarithmic scale对数级long term test长期试验long-time and accelerated stability长期和加速稳定性试验losses of activity活性丧失lot release批签发low molecular weight substances低分子量物质lower-observed effect level(LOEL)能观察到反应的最低量lymphocytic choriomeningitis virus(LCM)淋巴细胞性脉络丛脑膜炎病毒lyophilised cakes冻干粉饼lysate of cells细胞溶解物mammalian哺乳类manufacturing scale生产规模marker chromosome标志染色体marketing pack上市包装mass重量mass balance质量平衡mass spectrometry质谱master cell bank (MCB)主细胞库material balance物质平衡matrix基质、矩阵matrix system矩阵法matrixing 矩阵化设计maximum daily dose每日最大剂量mean kinetic temperature平均动力学温度metazoan cell culture后生动物细胞培养microbial cell culture微生物细胞培养microbial cells微生物细胞microbial contamination微生物污染microbial expression system微生物表达系统microbial limits微生物限度microbial metabolites微生物代谢物microbial proteases微生物蛋白酶microbial vaccine antigens微生物疫苗抗原microbiological testing微生物学试验minimum exposure time最低作用时间minimum of pilot plant试验规模minute virus of mice小鼠小病毒mirror image镜像mismatched S-S linked错连的S-S键mork run空白对照试验modified-/modifying release修饰释放modifying factor修正因子moisture level水分molar asorptivity克分子吸收molecular characteristics分子特性molecular confirmation分子构型molecular entities/entity分子实体molecular size分子大小monoclonal antibody单克隆抗体morphological analysis形态学分析mouse antibody production (MAP) test小鼠抗体产生试验mouse cytomegalovirus(MCMV)小鼠巨细胞病毒mouse encephalomyelitis virus(GDVⅡ)小鼠脑脊髓炎病毒mouse hepatitis virus(MHV)小鼠肝炎病毒mouse rotavirus(EDIM)小鼠小轮状病毒MuLV murine leukemia virus鼠白血病病毒murine hybridoma cell lines鼠杂交瘤细胞系mutations突变mycoplasma支原体myeloma cell line骨髓瘤细胞系national or international reference material国家或国际参比物质near ultraviolet lamp近紫外灯neural sugars中性糖new chemical entry 新化学体new dosage form新剂型new drug products/produce新药制剂new drug substance新原料药new molecular entities新分子体no effect level不产生反应的量noncovalent/convalent force非共价/共价键non-enveloped viruses非包膜病毒non-mammalian animal cell lines非哺乳动物细胞系non-recombinant cell-culture expression systems非重组细胞培养表达系统non-recombinant products/vaccines非重组制品/疫苗non-specific model virus 非特异模型病毒no-observed effect level不能观察到反应的量N-terminal sequencing N-端测序nuclear magnetic resonance核磁共振official procedure正式方法ointments软膏oligosaccharide pattern低聚核苷酸opacity浊度origins of replication复制起点osmolality摩尔渗透压浓度outdoor daylight室外阳光oxidation氧化oxygen consumption rates耗氧率package包装parainfluenza virus副流感病毒parallel control assays平行对照分析parent stability Guideline稳定性试验总指导原则patrental cell line母细胞系parenterals非肠道制剂particle size粒度particulate matter微粒parvoviruses细小病毒passage history of the cell line细胞系的传代史pathogenic agents致病因子pathogenicity致病性patterns of degradation降解方式peptide肽peptide map肽图percent recovery回收率periodic/skip testing定期检验/抽验permitted daily exposure允许的日接触量phage typing 噬菌体分型pharcodynamic studies药效学研究pharmacopoeial药典pharmacopoeial specifications药典规范pharmacopoeial standards药典标准phenotypic表型phosphorylation磷酸化作用photostability testing光稳定性试验physicochemical changes理化改变physicochemical methods物理化学方法physico-chemical properties物理化学特性pilot-plant scale试生产规模/中试规模piston release force活塞释放力piston travel force活塞移动力pivotal stability studies关键的稳定性研究plaque assays菌斑测定plasmid质粒plasmid banks质粒库plasminogen activators纤溶酶原激活素pneumonia virus of mice小鼠肺炎病毒Poisson distibution泊松分布polymorphic form多克隆抗体polymorphse chain reaction（PCR）聚合酶链式反应polymorphic form多晶性型polymorphs多晶型polyoma virus多瘤病毒pooled harvest集中回收population doubling细胞鼠倍增/群体倍增porcine猪post-approval批准后post-translational modification翻译后修饰post-translationally modified forms翻译后修饰形式potency效价potent功效potential adverse consequences潜在的不良后果potential excipients准赋形剂potential impurity潜在杂质potential new drug products准新药制剂potential new drug substances准新原料药potentiometric titrimetry电位滴定powders粉剂power outages and human error断电和人为错误preamble引言pre-approval or pre-liscense stage批准前或发证前阶段precision精密度preclinical and clinical studies临床前和临床研究precursors前体preliminary assessment初步评估preliminary cell bank初级细胞库preparation制剂preservative防腐剂primary cells原代细胞primary stability data主要稳定性数据primary stability study/formal study/formal stability study主要稳定性研究/正式研究/正式稳定性研究primary structure一级结构primer引物priming regimen(s)接种方式probability概率process characterization studies工艺鉴定研究process controls工艺控制process optimization工艺优化process parameters工艺参数process validation工艺确证process –related impurities工艺相关杂质product-related impurities产品相关杂质progenitor祖细胞prokaryotic cell原核细胞promoters启动子proposed commercial process模拟上市protected samples避光样品proteins蛋白质分析技术proteolysis蛋白水解protocol方案pseudopolymorphs伪多晶体pseudorabies virus假狂犬病毒purification纯化purified antigens纯化抗原purity纯度purity test纯度试验pyrogens热原试验qualification界定qualified 合格的quality standards质量标准quantal methods质反应测定法quantitation limit定量限度quantitative characteristics定量参数quantitative detection定量检测quantitative infectivity assays感染性定量测定quantitative method定量方法quantitative test定量试验quantitative virus病毒定量分析quantity含量racemate消旋体radiometers/lux meters测光仪/照度仪radiopharmaceutical放射性药物range范围rat antibody production (RAP) test大鼠抗体产生试验rationale基本原理raw material原材料raw material testing原材料测试rDNA technology重组DNA技术rDNA-modified cell substrates重组DNA修饰的细胞基质reagent试剂、反应物real condition真实条件real time 真实时间rebank 再建库receptor受体reclone再克隆recombinant cell-culture expression systems 重组细胞培养表达系统recombinant DNA protein products重组DNA蛋白质产品recomibinant-DNA-derived product重组DNA制品recombinant protein重组蛋白质reconstitution重新溶解redispersibility再分散性reduction factors下降因子reference material参比物质reference standard参比标准品regimen方案registration application注册申请regression analysis回归分析regulator/regulatory agencies管理机构related substances有关物质release limit出厂限度“relevant” viruses and “model” viruses“相关”病毒和“模型”病毒reovirus type3(Reo 3)呼吸肠病毒repeatability重复性reproducibility 重现性residual solvents残留溶剂residual sum of squares溶剂残留量resolution test分离度试验response factor响应因子restriction endonuclease mapping限制性内切酶图谱restriction fragment length polymorphism限制性片段长度多态性resuspension再悬浮retention time保留时间retest date再试验日期reverse transcriptase(RT)反转录酶reversed-phase chromatography反相色谱reverse-phase liquid chromatography反相液相色谱revived cells复苏的细胞rheological properties流体学特性risk-benefit analysis利弊分析robustness耐用性rodent retrovirus啮齿类动物逆转录病毒sampling采样scale-up放大scaling down缩小规模scope范围scrapie瘙痒病screening tests筛选试验SDS-PAGE/SDS-polyacrylamide gel electrophoresis十二烷基硫酸钠-聚丙烯酰胺凝胶电泳sealed ampoules密封安瓿secondary structure二级结构self-replicating agents自我复制因子semi-synthetic products半合成产品Sendai virus仙台病毒Sensitivity灵敏度Senescence老化Separation分离Serum血清Shear切变shelf life货价寿命shipment运输sialic acids唾液酸signal-to-noise信噪比Sindbis virus新德比病毒single-dose and multiple-dose packages单剂量和多剂量包装single-point measurements单点测定single-tiered banking system单级细胞库系统size exclusion chromatography分子排阻色谱skip lot testing随机试验slope of the regression line回归线的斜率solid oral doseage固体口服制剂solvates溶剂化物solvation溶剂化作用solvent溶剂species物种specific gravity比重specific objectionable bacteria控制菌specification规范specification limit规范限度specification –check质控规范specification-release出厂规范specifications规范specificity专属性specified impurities特定杂质specified light exposure特定的光照spectroscopic profiles光谱图spiked samples加料样品spiking experiments叠加试验splicing sequences剪接序列stabilizers稳定剂stability data稳定性资料stability evaluation稳定性评价stability proticol稳定性方案stability study duration稳定性试验期限stability testing稳定性试验stability-indicating profile反应稳定性指标standard deviation标准差standard stock solution标准储备液starting materials起始物statement/labeling说明/标签statistical analysis统计学分析sterility无菌storage condition放置条件strains品系stress condition强力破坏试验条件stress testing强力破坏试验storage conditions储存条件structural heterogeneity结构异质性subcultivations传代培养sulfhydryl groups and disulfide bridges巯基和二硫键sulfoxidation硫酰化support information辅助性资料surrogate test替代试验surrogates替代物suspensions混悬剂swine猪synthesis合成synthetic peptides合成肽syringeability灌注功能systemic exposure全身接触tablet cores片芯tandem repeats串联重复target molecule靶分子temperature changes温度变化terminology术语tertiary structure三级结构test criteria试验标准test intervals试验间隔test parameters试验参数testing frequency试验次数texture质地the method of least squares最小二乘法threshold limits阈值thymic virus胸腺病毒tip cap removal force滴帽移动力tissue-culture-infectious-dose(TCID)组织培养感染剂量titration滴定法tolerable daily intake可耐受的日摄入量toolan virus(Hi)图兰病毒topical formulations局部用药处方toxic impurity毒性杂质toxin毒素tranfection of matazoan cells后生动物细胞的转染transcrption转录transdermal systems透皮吸收系统transfection转染transfomation转化translational fidelity翻译的忠实性transmission electron microscopy电透镜transparent cover透明盖子truncated forms截短形式tumor necrosis factor肿瘤坏死因子tumorigenicity致瘤性two-tiered cell bank两级细胞库uncloned cell population未克隆的细胞群unicellular life forms单细胞生命形式unidentified impurities未确定杂质uniformity of content 含量均匀度uniformity of dosage units剂量单位的均匀度uniformity of fill装填均匀度uniformity of mass质量均匀度unitage单位universal tests/criteria常规试验/标准untransfected recipient cell line未转染的受体细胞系UV/visible wavelength紫外可见光波长Vacinnes疫苗Validation论证variant sequences变异序列variants 变异体vector载体vehicle载体/溶酶vesicular stomatitis virus小囊状口腔炎病毒viral clearance病毒清除viral clearance studies病毒清除研究viral contamination病毒污染viral geneme病毒基因组viral infectivity病毒感染性viral safety evaluation病毒安全评估viral vicinnes病毒性疫苗virucidal buffers杀病毒缓冲液virus load 病毒浓度virus titer病毒滴度viscosity粘度visible particulates可见颗粒visual appearance外观visual evaluation直观评价vitamins 维生素water of hydration结晶水well-defined testing program确定的试验项目western blot免疫印迹whole blood全血within-assay variation试验内变异working cell bank工作细胞库yeast酵母y-intercept y轴上的截距。