药品检验报告英语
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1、foreign trade(外贸)contract合同)invoice(发票)2、bill of lading(提单)L/C(信用证)buyer(买方)3、import(进口) export(出口)corporation(公司)4、textile(纺织品)telephone(电话)manager(经理)5、message(音信、文电)order(订单) trouble(麻烦)6、minute(分钟)agree(同意machinery(机械)7、sales(销售 receive(收到) cable(电报)8、customer 客户、顾客accepl接受choice 选择9、industrial 工业的product产品 terms条款10、important 重要sign 签字 each 每一个11、business 业务、生意 start 开始 wait等待12、sure 肯定的 service 服务rest 休息13、fair 交易会 spend 花费 certainly 当然14、goods 货物display 展示commodity 商品15、silk 丝绸 garment 服装sample 样品16、sell卖出 market 市场world 世界17example例of course 当然 popular 流行的18、policy 政策 visit 拜访 relation 关系19、past 过去的fact 事实 benefit 利益20commercial 商业 cooperate 合future 未来21、type 型号 specification 规格 price 价格22、FOB 离岸价 CIF 到岸价23、inspection 检验 test 检测 report 报告24、certificate 证书 stamp 印章health 健康25、quality 品质 weight 重量quantity数量26、wrong 错的colour 颜色 date 日期27、shipment 装船 answer 回答 delivery 交货28、size 尺码percent 百分之 toy 玩具29、packing 包装carton 纸箱 ilogram 公斤30、net weight 净重 confirmation 确认agent 代理人31beneficiary 受益人applicant 申请人 opening bank 开证行32、Certficate of Quality 品质证书Certificate of Weight 重量证书33、Certificate of Quantity 数量证书Certificate of Packing 包装证书34、Certificate of Health 健康证书Certificate of Quarantine 检疫证书35、Veterinary Certificate 兽医证书Sanitary Certificate 卫生证书36、Certificate of Origin 产地证书37、Certificate of Fumigation 熏蒸证书38、Fumigation/Disinfection Certificate 熏蒸/消毒证书39、Animal Health Certificate 动物卫生证书40、Phytosanitary Certificate 植物检疫证书41、Phytosanitary Certificate For Re-export 植物转口检疫证书42、3anitary Certificate For Conveyance 交通工具证书43、Quarantine Certificate For Conveyance 运输工具检疫证书44Veterinary Health Certificale 兽医卫生证书45、consignee 收货人consignor发货人description of good 品名、货物名称46、quantity/weight declared 报检数/重量47Contract No、合同号Invoice No、发票号48、place of arrival 到货地点 means of conveyance 运输工具49、date of arrival 到货日期B/L or Way Bill No、提单或运单号50 place of despatch 启运地date of inspection 检验日期51、date of completion of discharge 卸毕日期52Mark&No. 标记及号码destination 目的地53、Name and No. Of Conveyance 运输工具名称及号码54、Port of despatch 启运口岸 Port of destination 到达口岸55date of arrival/departure 到达/离境日期56、name and address of consignor 发货人名称及地址57、name and address of consignee 收货人名称及地址58、number and type of packages 包装种类及数量59、document 单据rule 规则bank 银行60、importer 进口商exporter 出口商trade mark 商标61container 集装箱 vessel 船 to order 待指定62、Plastic drum 塑料桶gunny bag 麻袋 wooden case 木箱63、packing material 包装材料 outer package 外包装64、flexible package 软包装 transparent package 透明包装65、wooden pallet 木托盘 corrugated carton 瓦楞纸箱66、plywood 胶合板箱 poly bag 塑料袋67、vacuum packaging 真空包装cushioning material 衬垫材料68、dozen 打 roll 卷 bundle 捆69water proof packing 防水包装rust proof packaging 防锈包装70、moisture proof packaging 防潮包装shockproof packaging 防震包装71、adhesive tape 压敏胶带 plastic foam 泡沫塑料72、long 长 high 高 thick 厚73、top 顶 bottom 底 side 边74、degree 度 wide 宽 deep 深75、fragile 易碎的 hard 硬的 sharp 锋利的76、packing sound 包装良好 no leakage 无渗漏77、total net weight 总净重叠 pumpkin seeds 南瓜子 garlic 大蒜78、bike 自行车 rubber shoes 胶鞋 game player 游戏机79、loud speaker 扬声器 citric acid 柠檬酸80inspection certificate 检验证书 certify 证明81Guangdong Native Product Import & Export Corporation. 广东土产进出口公司82The goods were packed In gunny bags of 50kgs net each. 货物用麻袋包装、每袋净重公斤83The quality of the above mentioned goods were in confor mity with the requirement of the contract No、JBD-089. 上述货物的品质符合JBD-089号合同的品质要求84、We need a Phytosanitary Certificate.我们需要一份植物检疫证书85、food inspection for export 出口食品检验86、Fill in this Application Form,please. 请填写一份申请。
ICS 01.040.03A 14备案号: 北京市地方标准DB公共场所双语标识英文译法第5部分 医疗卫生English Translation of Public SignsPart 5:Health and Medicine(报批稿)北京市质量技术监督局 发布DB11/T 334.5—2006前言DB11/T 334《公共场所双语标识英文译法》标准分为以下几个部分:——第0部分:通则;——第1部分:道路交通;——第2部分:景区景点;——第3部分:商业服务业;——第4部分:体育场馆;——第5部分:医疗卫生。
本部分为DB11/T 334的第5部分。
本部分附录A为规范性附录。
本部分由北京市人民政府外事办公室提出并归口。
本部分起草单位:北京市人民政府外事办公室、北京市卫生局、北京市标准化协会、中国对外翻译出版公司。
本部分主要起草人:刘洋、鲍华、卢津兰、宋国建、刘畅、王瑛、张晶晶、张京生、戴岚、卢京昌、刘雪涛、王海虹、田川、周巧霖、李晓林本部分2006年××月××日首次发布。
IDB11/T 334.5—2006公共场所双语标识英文译法第5部分医疗卫生1 范围DB11/T 334本部分规定了北京市医疗卫生双语标识英文译法的原则。
本部分适用于医疗卫生场所中的英文标识译法。
2 规范性引用文件下列文件中的条款通过本部分的引用而成为本部分的条款。
凡是注日期的引用文件,其随后所有的修改单(不包括勘误的内容)或修订版均不适用于本部分,然而,鼓励根据本部分达成协议的各方研究是否可使用这些文件的最新版本。
凡是不注日期的引用文件,其最新版本适用于本部分。
GB/T 16159 汉语拼音正词法基本规则3 术语和定义下列术语和定义适用于本部分。
3.1 医疗卫生health and medicine医疗卫生是指以医疗、预防、保健、医疗教育和科研工作为功能,由不同层次的医疗卫生机构组成。
4 分类4.1 医疗卫生的英语标识按内容可分为:警示提示信息、功能设施信息。
cra英文自我介绍篇一:cRa常见英文SFdaGlossary:GcP,GLP,TRiaL accuracy准确度activecontrol,ac阳性对照,活性对照adversedrugreaction,adR药物不良反应adverseevent,aE不良事件adversemedicalevents不良医学事件adversereaction药物不良反应alb白蛋白aLd(approximateLethaldose)近似致死剂量aLP碱性磷酸酶alphaspendingfunction消耗函数aLT丙氨酸氨基转换酶analysissets统计分析的数据集approval批准assistantinvestigator助理研究者aST天门冬酸氨基转换酶aTR衰减全反射法aUcss稳态血药浓度-时间曲线下面积audit稽查auditorinspection稽查/视察auditreport稽查报告auditor稽查员Bias偏性,偏倚Bioequivalence生物等效应Blankcontrol空白对照Blindcodes编制盲底Blindreview盲态审核Blindreview盲态检查Blindingmethod盲法Blinding/masking盲法,设盲Block分段Block层Blocksize每段的长度BUn尿素氮carryovereffect延滞效应casehistory病历casereportform病例报告表casereportform/caserecordform,cRF病例报告表,病例记录表categoricalvariable分类变量cav平均浓度cd圆二色谱cL清除率clinicalequivalence临床等效应clinicalstudy临床研究clinicalstudyreport临床试验的总结报告clinicaltrial临床试验clinicaltrialapplication,cTa临床试验申请clinicaltrialexemption,cTX临床试验免责clinicaltrialprotocol,cTP临床试验方案clinicaltrial/studyreport临床试验报告cmax峰浓度co-investigator合作研究者comparison对照compliance依从性compositevariable复合变量computer-assistedtrialdesign,caTd计算机辅助试验设计confidenceinterval可信区间confidencelevel置信水平consistencytest一致性检验contractresearchorganization,cRo合同研究组织contract/agreement协议/合同controlgroup对照组coordinatingcommittee协调委员会crea肌酐cRF(casereportform)病例报告表crossoverdesign交叉设计cross-overstudy交叉研究css稳浓度cure痊愈datamanagement数据管理database建立数据库descriptivestatisticalanalysis描述性统计分析dF波动系统dichotomies二分类diviation偏差documentation记录/文件dose-reactionrelation剂量-反应关系doubleblinding双盲doubledummy双模拟doubledummytechnique双盲双模拟技术double-blinding双盲dropout脱落dSc差示扫描热量计Effectiveness疗效Electronicdatacapture,Edc电子数据采集系统Electronicdataprocessing,EdP电子数据处理系统Emergencyenvelope应急信件Endpoint终点Endpointcriteria/measurement终点指标Equivalence等效性Essentialdocumentation必须文件Ethicscommittee伦理委员会Excellent显效Exclusioncriteria排除标准Factorialdesign析因设计Failure无效,失败Finalpoint终点Fixed-doseprocedure固定剂量法Forcedtitration强制滴定Fullanalysisset全分析集Gc-FTiR气相色谱-傅利叶红外联用Gc-mS气相色谱-质谱联用Genericdrug通用名药Globalassessmentvariable全局评价变量GLU血糖Goodclinicalpractice,GcP药物临床试验质量管理规范Goodmanufacturepractice,GmP药品生产质量管理规范Goodnon-clinicallaboratorypractice,GLP药物非临床研究质量管理规范Groupsequentialdesign成组序贯设计Healtheconomicevaluation,HEV健康经济学评价Hypothesistest假设检验Hypothesistesting假设检验internationalconferenceofHarmonization,icH人用药品注册技术要求国际技术协调会,国际协调会议improvement好转inclusioncriteria入选标准independentethicscommittee,iEc独立伦理委员会informationconsentform,icF知情同意书informationgathering信息收集informedconsent,ic知情同意initialmeeting启动会议inspection视察/检查institutioninspection机构检查institutionreviewboard,iBR机构审查委员会intentiontotreat意向治疗(——临床领域)intention-to–treat,iTT意向性分析(-统计学)interactivevoiceresponsesystem,iVRS互动式语音应答系统interimanalysis期中分析investigator研究者investigator'sbrochure,iB研究者手册iR红外吸收光谱Ka吸收速率常Lastobservationcarryforward,LocF最接近一次观察的结转Lc-mS液相色谱-质谱联用Ld50板数致死剂量Logiccheck逻辑检查LoQ(LimitofQuantitation)定量限LocF,Lastobservationcarryforward最近一次观察的结转Lostoffollowup失访marketingapproval/authorization上市许可证matchedpair匹配配对missingvalue缺失值mixedeffectmodel混合效应模式monitor监查员monitoring监查monitoringreport监查报告mRT平均滞留时间mS质谱mS-mS质谱-质谱联用mTd(maximumTolerateddose)最大耐受剂量multicentertrial多中心试验multi-centertrial多中心试验newchemicalentity,ncE新化学实体newdrugapplication,nda新药申请nmR核磁共振谱non-clinicalstudy非临床研究non-inferiority非劣效性non-parametricstatistics非参数统计方法obedience依从性odR旋光光谱open-blinding非盲open-label非盲optionaltitration随意滴定originalmedicalrecord原始医疗记录outcome结果outcomeassessment结果指标评价outcomemeasurement结果指标outlier离群值Parallelgroupdesign平行组设计Parameterestimation参数估计Parametricstatistics参数统计方法Patientfile病人档案Patienthistory病历Perprotocol,PP符合方案集Placebo安慰剂Placebocontrol安慰剂对照Polytomies多分类Power检验效能Precision精密度Preclinicalstudy临床前研究Primaryendpoint主要终点Primaryvariable主要变量Principalinvestigator主要研究者Principleinvestigator,Pi主要研究者Productlicense,PL产品许可证Protocol试验方案Protocol试验方案Protocolamendment方案补正Qualityassuranceunit,QaU质量保证部门Qualityassurance,Qa质量保证Qualitycontrol,Qc质量控制Querylist,queryform应用疑问表Randomization随机化Randomization随机Rangecheck范围检查Ratingscale量表Regulatoryauthorities,Ra监督管理部门Replication可重复RSd日内和日间相对标准差Runin准备期Safetyevaluation安全性评价Safetyset安全性评价的数据集Samplesize样本含量Samplesize样本量,样本大小Scaleoforderedcategoricalratings有序分类指标Secondaryvariable次要变量Sequence试验次序Seriousadverseevent,SaE严重不良事件Seriousadversereaction,SaR 严重不良反应Seriousness严重性Severity严重程度Significantlevel检验水准Simplerandomization简单随机Singleblinding单盲Single-blinding单盲Siteaudit试验机构稽查SoP试验室的标准操作规程Sourcedataverification,SdV原始数据核准Sourcedata,Sd原始数据Sourcedocument,Sd原始文件篇二:cRa自我介绍我从事cra的一点体会[转]一年前我已从事临床工作近五年,考了中级职称后改的行。
公共场所双语标识英文译法(医疗卫生部分)1 范围DB11/T 334本部分规定了北京市医疗卫生双语标识英文译法的原则。
本部分适用于医疗卫生场所中的英文标识译法。
2 规范性引用文件下列文件中的条款通过本部分的引用而成为本部分的条款。
凡是注日期的引用文件,其随后所有的修改单(不包括勘误的内容)或修订版均不适用于本部分,然而,鼓励根据本部分达成协议的各方研究是否可使用这些文件的最新版本。
凡是不注日期的引用文件,其最新版本适用于本部分。
GB/T 16159 汉语拼音正词法基本规则3 术语和定义下列术语和定义适用于本部分。
3.1 医疗卫生health and medicine医疗卫生是指以医疗、预防、保健、医疗教育和科研工作为功能,由不同层次的医疗卫生机构组成。
4 分类4.1 医疗卫生的英语标识按内容可分为:警示提示信息、功能设施信息。
4.2 其中功能设施信息分为:通用信息、医院系统信息、疾病预防控制中心系统信息、急救中心系统信息、血液中心系统信息。
4.3 警示提示信息见附录A.1。
4.4 通用信息见附录A.2.1,医院系统信息见附录A.2.2,血液中心系统信息见附录A.2.3,疾病预防控制中心系统信息见附录A.2.4。
5 要求5.1 警示提示信息译法原则按照本标准第0部分的规定。
5.2 功能设施信息5.2.1 国际通用功能设施采用相应的英文词语,如医院Hospital、疾病预防控制中心Center for Disease Prevention and Control (CDC)、诊室Consulting Room、血液中心Blood Center、卫生监督所Health Inspection Institute。
5.2.2 医疗卫生标志上的地名通常采用汉语拼音标注,汉语拼音用法应符合GB/T 16159的要求,如宣武医院Xuanwu Hospital;已经被社会普遍接受的单位名称,如协和医院Peking Union Medical College Hospital,可延续此用法。
专业术语、缩略语中英对照表缩略语英文全称中文全称ABE Average Bioequivalence 平均生物等效性AC Active control 阳性对照ADE Adverse Drug Event 药物不良事件ADR Adverse Drug Reaction 药物不良反应AE Adverse Event 不良事件AI Assistant Investigator 助理研究者ALB Albumin 白蛋白ALD Approximate Lethal Dose 近似致死剂量ALP Alkaline phosphatase 碱性磷酸酶ALT Alanine aminotransferase 丙氨酸转氨酶ANDA Abbreviated New Drug Application 简化新药申请ANOV A Analysis of variance 方差分析AST Aspartate aminotransferase 天冬氨酸转氨酶ATR Attenuated total reflection 衰减全反射法BA Bioavailability 生物利用度BE Bioequivalence 生物等效性BMI Body Mass Index 体质指数BUN Blood urea nitrogen 血尿素氮CATD Computer-assisted trial design 计算机辅助试验设计CDER Center of Drug Evaluation and Research 药品评价和研究中心CFR Code of Federal Regulation 美国联邦法规CI Co-Investigator 合作研究者CI Confidence Interval 可信区间COI Coordinating Investigator 协调研究者CRC Clinical Research Coordinator 临床研究协调者CRF Case Report/Record Form 病历报告表/病例记录表CRO Contract Research Organization 合同研究组织CSA Clinical Study Application 临床研究申请CTA Clinical Trial Application 临床试验申请CTP Clinical Trial Protocol 临床试验方案CTR Clinical Trial Report 临床试验报告CTX Clinical Trial Exemption 临床试验免责CHMP Committee for Medicinal 人用药委会Products for Human UseDSC Differential scanning 差示扫描热量计DSMB Data Safety and monitoring Board 数据安全及监控委员会EDC Electronic Data Capture 电子数据采集系统EDP Electronic Data Processing 电子数据处理系统EWP Europe Working Party 欧洲工作组FDA Food and Drug Administration 美国食品与药品管理局FR Final Report 总结报告GCP Good Clinical Practice 药物临床试验质量管理规范GCP Good Laboratory Practice 药物非临床试验质量管理规范GLU Glucose 葡萄糖GMP Good Manufacturing Practice 药品生产质量管理规范HEV Health economic evaluation 健康经济学评价IB Investigator’s Brochure研究者手册IBE IndividualBioequivalence 个体生物等效性IC Informed Consent 知情同意ICF Informed Consent Form 知情同意书ICH International Conference on Harmonization 国际协调会议IDM Independent Data Monitoring 独立数据监察IDMC Independent Data Monitoring Committee 独立数据监察委员会IEC Independent Ethics Committee 独立伦理委员会IND Investigational New Drug 新药临床研究IRB Institutional Review Board 机构审查委员会ITT Intention-to –treat 意向性分析IVD In Vitro Diagnostic 体外诊断IVRS Interactive Voice Response System 互动语音应答系统LD50 Medial lethal dose 半数致死剂量LLOQ Lower Limit of quantitation 定量下限LOCF Last observation carry forward 最接近一次观察的结转LOQ Limit of Quantitation 检测限MA Marketing Approval/Authorization 上市许可证MCA Medicines Control Agency 英国药品监督局MHW Ministry of Health and Welfare 日本卫生福利部MRT Mean residence time 平均滞留时间MTD Maximum Tolerated Dose 最大耐受剂量ND Not detectable 无法定量NDA New Drug Application 新药申请NEC New Drug Entity 新化学实体NIH National Institutes of Health 国家卫生研究所(美国)NMR Nuclear Magnetic Resonance 核磁共振PD Pharmacodynamics 药效动力学PI Principal Investigator 主要研究者PK Pharmacokinetics 药物动力学PL Product License 产品许可证PMA Pre-market Approval (Application) 上市前许可(申请)PP Per protocol 符合方案集PSI Statisticians in the Pharmaceutical Industry 制药业统计学家协会QA Quality Assurance 质量保证QAU Quality Assurance Unit 质量保证部门QC Quality Control 质量控制QWP Quality Working Party 质量工作组RA Regulatory Authorities 监督管理部门REV Revision 修订SA Site Assessment 现场评估SAE Serious Adverse Event 严重不良事件SAP Statistical Analysis Plan 统计分析计划SAR Serious Adverse Reaction 严重不良反应SD Source Data/Document 原始数据/文件SD Subject Diary 受试者日记SDV Source Data Verification 原始数据核准SEL Subject Enrollment Log 受试者入选表SFDA State Food and Drug Administration 国家食品药品监督管理局SI Sponsor-Investigator 申办研究者SI Sub-investigator 助理研究者SIC Subject Identification Code 受试者识别代码SOP Standard Operating Procedure 标准操作规程SPL Study Personnel List 研究人员名单SSL Subject Screening Log 受试者筛选表T&R Test and Reference Product 受试和参比试剂T-BIL Total Bilirubin 总胆红素T-CHO Total Cholesterol 总胆固醇TG Thromboglobulin 血小板球蛋白Tmax Time of maximum concentration 达峰时间TP Total proteinum 总蛋白UAE Unexpected Adverse Event 预料外不良事件WHO World Health Organization 世界卫生组织WHO- WHO International Conference WHO 国际药品管理当局会议ICDR A of Drug Regulatory AuthoritiesAberrant result 异常结果Absorption phase 吸收相Absorption 吸收Accuracy 准确度Accurate 精密度Administer 给药Amendment修正案Approval 批准Assess 估计Audit Report 稽查报告Audit 稽查Auditor 稽查员Analytical run/batch:分析批Benefit 获益Bias 偏性,偏倚Bioequivalence 生物等效Biosimilar /Follow-on biologics 生物仿制药Blank Control 空白对照Blind codes 编制盲底Blind review 盲态检查/盲态审核Blinding method 盲法Blinding/masking 盲法/设盲Block size 每段的长度Block 层/分段BCS 生物药剂学分类系统Carryover effect 延滞效应Case history 病历Clinical equivalence 临床等效性Clinical study 临床研究Clinical Trial Report 临床试验报告Comparison 对照Compensation 补偿,赔偿金Compliance 依从性Concomitant 伴随的Conduct 行为Confidence level 置信水平Consistency test 一致性检验Contract/ agreement 协议/合同Control group 对照组Coordinating Committee 协调委员会Crossover design 交叉设计Cross-over Study 交叉研究Cure 痊愈Data management 数据管理Descriptive statistical analysis 描述性统计分析Dichotomies 二分类Dispense 分布Diviation 偏差Documentation 记录/文件Dosage forms 剂型Dose dumping 剂量倾卸(药物迅速释放入血而达到危险浓度)Dose-reaction relation 剂量-反应关系Double blinding 双盲Double dummy 双模Drop out 脱落Effectiveness 疗效Elimination phase 消除相Emergency envelope 应急信件Enantiomers 对映体End point 终点Endpoint criteria/ measurement 终点指标Enterohepatic recycling 肠肝循环Essential Documentation 必需文件Ethical 伦理的Ethics committee 伦理委员会Evaluate 评估Exclusion Criteria 排除标准Excretion 排泄Expedite 促进Extrapolated 外推的Essentially similar product:基本相似药物Factorial design 析因设计Failure 无效,失败Finacing 财务,资金Final point 终点First pass metabolism 首过代谢Fixed-dose procedure 固定剂量法Full analysis set 全分析集GC-FTIR 气相色谱-傅利叶红外联用GC-MS 气相色谱-质谱联用Generic drug 通用名药Gene mutation 基因突变Genotoxicity tests 生殖毒性试验Global assessment variable 全局评价变量Group sequential design 成组序贯设计Hypothesis test 假设检验Highly permeable:高渗透性Highly soluble:高溶解度Highly variable drug:高变异性药物Highly:Variable Drug 高变异性药物HVDP:高变异药物制剂Identification 鉴别,身份证Improvement 好转In vitro 体外In vivo 体内Inclusion Criteria 入选表准Information Gathering 信息收集Initial Meeting 启动会议Inspection 检察/视察Institution Inspection 机构检察Instruction 指令,说明Integrity 完整,正直Intercurrent 中间发生的,间发的Inter-individual variability 个体间变异性Interim analysis 期中分析Investigational Product 试验药物Investigator 研究者Involve 引起,包括IR 红外吸收光谱Innovator Product:原创药Ka 吸收速率常LC-MS 液相色谱-质谱联用logarithmic transformation 对数转换Logic check 逻辑检查Lost of follow up 失访Mask 面具,掩饰Matched pair 匹配配对Metabolism 代谢Missing value 缺失值Mixed effect model 混合效应模式Modified release products 改良释放剂型Monitor 监查员Monitoring Plan 监察计划Monitoring Report 监察报告MS-MS 质谱-质谱联用Multi-center Trial 多中心试验Negative 阴性,否定的Non-clinical Study 非临床研究Non-inferiority 非劣效性Non-Linear Pharmacokinetics 非线性药代动力学Non-parametric statistics 非参数统计方法NTID:窄治疗指数制剂Obedience 依从性Open-blinding 非盲Open-label 非盲Original Medical Record 原始医疗记录Outcome Assessment 结果评价Outcome measurement 结果指标Outlier 离群值OIP 经口服吸收药物Parallel group design 平行组设计Parameter estimation 参数估计Parametric statistics 参数统计方法Patient file 病人档案Patient History 病历Per protocol,PP 符合方案集Permeability 渗透性Pharmacodynamic characteristics 药效学特征Pharmacokinetic characteristics 药代学特征Placebo Control 安慰剂对照Placebo 安慰剂Polytomies 多分类Post-dosing postures 给药后坐姿Potential 潜在的Power 检验效能Precision 精密度Preclinical Study 临床前研究Precursor 母体前体Premature 过早的,早发Primary endpoint 主要终点Primary variable 主要变量Prodrug 药物前体Protocol amendment 方案补正Protocol Amendments 修正案Protocol 试验方案Quality Control Sample:质控样品Rapidly dissolving:快速溶出Racemates 外消旋物Randomization 随机/随机化Range check 范围检Rating scale 量表Recruit 招募,新会员Replication 可重复Retrieval 取回,补修Revise 修正Risk 风险Run in 准备期Safety evaluation 安全性评价Safety set 安全性评价的数据集Sample Size 样本量、样本大小Sampling schedules 采血计划Scale of ordered categorical ratings 有序分类指标Secondary variable 次要变量Sequence 试验次序Seriousness 严重性Severity 严重程度Significant level 检验水准Simple randomization 简单随机Single Blinding 单盲Site audit 试验机构稽查Solubility 溶解度Specificity 特异性Specify 叙述,说明Sponsor-investigator 申办研究者Standard curve 标准曲线Statistical model 统计模型Statistical tables 统计分析表Steady state 稳态Storage 储存Stratified 分层Study Audit 研究稽查Study Site 研究中心Subgroup 亚组Sub-investigator 助理研究者Subject Enrollment Log 受试者入选表Subject Enrollment 受试者入选Subject Identification Code List 受试者识别代码表Subject Recruitment 受试者招募Subject Screening Log 受试者筛选表Subject 受试者Submit 交付,委托Superiority 检验Supplemental 增补的Supra-bioavailability 超生物利用度(试验药的生物利用度大于对照药)Survival analysis 生存分析System Audit 系统稽查SmPC:药品说明书Standard Sample:标准样品Target variable 目标变量Treatment group 试验组Trial error 试验误差Trial Initial Meeting 试验启动会议Trial Master File 试验总档案Trial Objective 试验目的Trial site 试验场所Triple Blinding 三盲Two one-side test 双单侧检验Therapeutic equivalence:治疗等效性Un-blinding 破盲/揭盲Verify 查证、核实Visual analogy scale 直观类比打分法Vulnerable subject 弱势受试者Wash-out Period 洗脱期Well-being 福利,健康Withdraw 撤回,取消药代动力学参数Ae(0-t):给药到t时尿中排泄的累计原形药。
【分享】药品检验报告中的一些词语的英文翻译检验报告Certificate of analysis化工有限公司chemical CO. , LTD制药(药业)有限公司Pharmaceutical co. ,Ltd.化工厂CHEMICAL PLANT精细化工有限公司FINE CHEMICAL CO., LTD品名PRODUCT //title批号batch NO.生产日期manufacturing date // manu. Date检验日期Analysis date有效期Exp date // expiry date检验标准quality standard //inspecting basis //Specification数量QUANTITY 报告日期report date 包装规格package企业标准Company Standard//enterprise standard检查项目test items//analytical items性状appearance // characteristics//description//Character分子式molecular formula 分子量molecular wt化学式Chemical formula鉴别identification溶液外观appearance of solution澄清度&颜色clarity & color白色或类白色结晶粉末white or almost white crystalline powder味微苦 a little bitter taste无色无味odorless,smelless酸碱度acidity and alkalinity铅盐Plumbum salts 砷盐Arsonium salts有关物质related substances 分为:individual impurity substance NMT….;total impurity substance NMT。
Accuracy 准确度AC -Active Control 阳性对照、活性对照AE(Adverse Event)不良事件ADE (Adverse Drug Event)药物不良事件ADR(Adverse Drug Reaction)药物不良反应Adverse medical events 不良医学事件Alpha spending function 消耗函数Analysis sets 统计分析的数据集Approval 批准ALD(Approximate Lethal Dose)近似致死剂量AI(Assistant Investigator)助理研究者Audit 稽查Auditor 稽查员Audit Report 稽查报告Baseline 基线Bias 偏性,偏倚Bioequivalence 生物等效应Blank Control 空白对照Blind codes 编制盲底Blind review 盲态审核/检查Blinding method 盲法Blinding/Masking 盲法/设盲Block 分段/层Block size 每段的长度BMI(Body Mass Index )体质指数BD(Business Development):商务拓展Carryover effect 延滞效应Case History 病历Case Record/Medical History 病历CRF(Case Report Form)病例报告表Categorical variable 分类变量Cav 平均浓度CRF- Case Report Form 病例报告表CL 清除率Clinical equivalence 临床等效应CM(Clinical Monitoring/Operation):临床监查/运营CRA(Clinical Research Associate):临床监查员CRC(Clinical Research Coordinator):临床研究协调员CRO(Contract Research Organization)合同研究组织CS/NCS-Clinical Significant/Non-Clinical Significant有临床意义/无临床意义Clinical study 临床研究CSA(Clinical Study Application)临床研究申请Clinical study report 临床试验的总结报告Clinical Trial 临床试验Clinical trial application, CTA 临床试验申请Clinical trial exemption, CTX 临床试验免责CTP(Clinical Trial Protocol)临床试验方案CTR(Clinical Trial Report)临床试验报告Cmax 峰浓度CI(Co-investigator)合作研究者Comparison 对照Compliance 依从性Composite variable 复合变量Computer-assisted trial design, CATD计算机辅助试验设计CM -Concomitant Medication 合并用药Confidence interval 可信区间Confidence level 置信水平Consistency test 一致性检验Contract/Agreement 协议/合同Control group 对照组Coordinating Committee 协调委员会COI (Coordinating Investigator )协调研究者Crossover design 交叉设计Cross-over study 交叉研究CV(Curriculum Vitae):简历CFDA - China Food and Drug Administration国家食品药品监督管理局SFDA(State Food and Drug Administration)国家食品药品监督管理局Database 建立数据库DM(Data Management):临床数据管理员DOB-Date of Birth 出生日期DSMB(Data Safety and monitoring Board)数据安全及监控委员会Descriptive statistical analysis 描述性统计分析Demography 人口统计学Deviation 偏差Documentation 记录/文件Dose Discontinuation 剂量终止(完全终止)Dose-reaction relation 剂量-反应关系Dose Reduce 剂量降低Dose Interrupt 剂量中断(暂停)Double blinding 双盲Double dummy 双模拟Double dummy technique 双盲双模拟技术Drug Accountability 药物清点Drug Administration 药物使用Drug Destroy 药物销毁Drug Dispense 药物分发Drop out 脱落Drug Receive 药物接收Drug Return 药物返还Drug Storage 药物储存Effectiveness 疗效EDC(Electronic Data Capture)电子数据采集EDP(Electronic Data Processing)电子数据处理系统ECG-Electrocardiogram 心电图Emergency envelope 应急信件End point 终点Endpoint criteria/ measurement 终点指标Essential Documentation 必需文件Exclusion Criteria 排除标准Enrollment 入组Equivalence 等效性Essential documents 必需文件Ethics committee 伦理委员会Excellent 显效Exclusion Criteria 排除标准FDA- Food and Drug Administration美国食品与药品监督管理局Factorial design 析因设计Failure 无效,失败Final point 终点FR (Final Report )总结报告FPI/FSI-First Patient/Subject In 首例受试者入组Fixed-dose procedure 固定剂量法Follow Up 随访Forced titration 强制滴定Full analysis set 全分析集FTE(Full-Time Equivalent):工作量Generic drug 通用名药Global assessment variable 全局评价变量Grade 级别GCP- Good Clinical Practice 药物临床试验质量管理规范GMP- Good Manufacturing Practice药品生产质量管理规范Good non-clinical laboratory practice, GLP药物非临床研究质量管理规范Health economic evaluation, HEV 健康经济学评价Height 身高Hypothesis testing 假设检验Inclusion Criteria 入组标准IDM(Independent Data Monitoring)独立数据监察IDMC(Independent Data Monitoring Committee)独立的数据监查委员会IEC(Independent Ethics Committee)独立伦理委员会Informed consent, IC 知情同意ICF(Informed Consent Form)知情同意书Information Gathering 信息收集Initial Meeting 启动会议Institution Inspection 机构检察IRB(Institutional Review Board)机构审查委员会Inspection 视察/检查Intention to treat 意向治疗(临床领域)Intention-to –treat, ITT 意向性分析(统计学)Interactive Voice Response System, IVRS互动式语音应答系统Interim analysis 期中分析IWRS- Interactive Web Response System交互式网络应答系统Investigator 研究者Investigational Product 试验药物IND(Investigational New Drug):新药临床研究Improvement 好转ICH(International Conference on Harmonization)人用药品注册技术要求国际技术协调会IVD(In Vitro Diagnostic)体外诊断Investigator 研究者IB- Investigator’s Brochure 研究者手册ISF(Investigator Site File):研究者文件夹ISA(Investigator Study Agreement):研究者合同IP-Investigational Product 研究产品Investigational Site 研究中心Labeling 标签Laboratory Assessment 实验室评估LPI/LSI-Last Patient/Subject In 末例受试者入组LPO/LSO-Last Patient/Subject Out 末例受试者出组LOCF(Last observation carry forward)最近一次观察的结转LD50 半数致死剂量Life threatening 危急生命Logic check 逻辑检查LM(Line Manager):直线经理LOQ (Limit of Quantization) 定量限Lost of follow up 失访Matched pair 匹配配对MA (Marketing Approval/Authorization)上市许可证MTD(Maximum Tolerated Dose)最大耐受剂量Medication No. 研究药品编号MCA(Medicines Control Agency)英国药品监督局MHW (Ministry of Health and Welfare)日本卫生福利部Mild 轻度Moderate 中度Severe 重度Missing value 缺失值Mixed effect model 混合效应模式Monitor 监察员Monitoring 监察Monitoring Plan 监察计划Monitoring Report 监察报告MRT 平均滞留时间Multi-center trial 多中心试验New chemical entity, NCE 新化学实体NDA(New Drug Application)新药申请NEC(New Drug Entity)新化学实体NIH(National Institutes of Health)国家卫生研究所(美国)Non-clinical study 非临床研究Non-inferiority 非劣效性Non-parametric statistics 非参数统计方法Obedience 依从性Open-blinding/ label 非盲Optional titration 随意滴定Outcome 结果Outcome assessment 结果指标评价Outcome measurement 结果指标Outlier 离群值OS-Overall Survival 总生存期Overdose 药物过量Original Medical Record 原始医疗记录Packaging 包装Parallel group design 平行组设计Parameter estimation 参数估计Parametric statistics 参数统计方法Patient File 病人档案Patient History 病历Per protocol, PP 符合方案集Physical Exam 体格检查PV(Pharmacovigilance):药物警戒Placebo 安慰剂Placebo control 安慰剂对照Polytomies 多分类Power 检验效能Precision 精密度Preclinical study 临床前研究PMA(Pre-market Approval (Application))上市前许可(申请)Primary endpoint 主要终点Primary variable 主要变量PL (Product License)产品许可证PI(Project Investigator)主要研究者PM(Project Manager):项目经理Protocol 试验方案Protocol Amendments 修正案PD(Protocol Deviation):方案偏离PV(Protocol Violation):方案违背Pulse/Heart rate 脉搏/心率PSI(Statisticians in the Pharmaceutical Industry)制药业统计学家协会Quality assurance unit, QAU 质量保证部门QA- Quality Assurance 质量保证QC-Quality Control 质量控制Quantity 数量Query list, query form 应用疑问表Race 种族Randomization 随机化Randomized, Double-blind Study 随机对照双盲试验Range check 范围检查Rating scale 量表Reaction 严重的非预期疑似相关的药品不良反应Recruitment 招募RA(Regulatory Authorities)监督管理部门Replication 可重复Requires or prolongs hospitalization导致或延长住院时间Results in death 导致死亡Run in 准备期Reference Product 参比制剂Safety Assessment/Evaluation 安全评估Safety set 安全性评价的数据集Sample size 样本量Screening 筛选Secondary variable 次要变量Sequence 试验次序SAE(Serious Adverse Event)严重不良事件SAR(Serious Adverse Reaction)严重不良反应SUSAR=Serious and Unexpected Suspected Adverse Scale of ordered categorical ratings 有序分类指标Seriousness 严重性(性质)Severity 严重程度(程度)Significant level 检验水准Simple Randomization 简单随机、样本量、样本大小Single Blinding 单盲SA(Site Assessment)现场评估Site audit 试验机构稽查SCV(Site Close-out Visit):中心关闭访视SIV(Site Initiation Form):中心启动访视SIF(Site Information Form):中心信息表SMO(Site Management Organization)临床研究现场管理组织SMV(Site Monitoring Visit):中心监查访视SSV(Site Selection Visit):中心筛选访视SVR(Site Visit Report):中心访视报告Specificity 特异性Sponsor 申办者SI(Sponsor-Investigator)申办研究者SD -Source Data/Document/Documentation原始数据/文件SDV(Source Data Verification)原始数据核查Standard curve 标准曲线SOP(Standard Operation Procedure)标准操作规程Statistic 统计量SAP(Statistical Analysis Plan)统计分析计划Statistical Methods 统计学方法Statistical model 统计模型Statistical tables 统计分析表Stratified 分层Study Audit 研究稽查Study Completion 研究完成Study Design 研究设计Study Endpoint 研究终点Study Objective 研究目的SPL(Study Personnel List)研究人员名单Study Procedure 研究流程Study Site 研究中心Study Termination 研究终止SIC(Subject Identification Code):受试者识别代码SI(Sub-investigator)助理研究者Subgroup 亚组Subject 受试者SD(Subject Diary)受试者日记Subject Enrollment 受试者入选SIC (Subject Identification Code)受试者识别代码Subject Recruitment 受试者招募SSL(Subject Screening Log)受试者筛选表Superiority 检验Survival analysis 生存分析System audit 系统稽查Systolic Blood Pressure 收缩压SEL (Subject Enrollment Log )受试者入选表System Audit 系统稽查Synopsis 摘要T1/2 消除半衰期Target variable 目标变量Temperature 体温T&R(Test and Reference Product )受试和参比试剂Test Product 受试制剂Tmax 峰时间Transformation 变量变换Treatment Allocation 治疗分配Treatment group 试验组Trial error 试验误差Trial Initial Meeting 试验启动会议TMF(Trial Master File):试验主文件夹Trial Objective 试验目的Trial site 试验场所Triple Blinding 三盲Two one-side test 双单侧检验Un-blinding 揭盲、破盲UAE(Unexpected Adverse Experience)非预期的不良事件UAE (Unexpected Adverse Event )预料外不良事件Variable 变量Variability 变异Visual analogy scale 直观类比打分法Visual check 人工检查Vital Signs 生命体征Visit 访视Visit Window 访视窗口期Out of Visit Window 超窗Vulnerable subject 弱势受试者Wash-out 洗脱、清洗Wash-out Period 洗脱期Well-being 福利,健康Weigh 体重Withdrawal 脱落WHO(World Health Organization)世界卫生组织。
1.词汇和短语:常用专业短语:●Organization and Personnel 组织和人员●Responsibilities of quality control unit. 质量部门职责●Personnel Qualifications. 人员资格●Personnel responsibilities. 人员职责●Consultants. 顾问●Buildings and Facilities 建筑和设备●Design and construction features. 设计和建造●Lighting. 照明●Ventilation, air filtration, air heating and cooling. 送风,空气过滤,空气加热和冷却●Plumbing.Sewage and refuse. 泵,垃圾和废弃物●Washing and toilet facilities. 清洁和盥洗设备●Sanitation. Maintenance Equipment 灭菌和设备维护●Equipment design, size, and location. 设备的设计,型号,位置●Equipment construction. 设备结构●Equipment cleaning and maintenance 设备清洁和维护.●Automatic, mechanical, and electronic equipment. 自动,机械和电子设备●Filters. 过滤●Control of Components and Drug Product Containers and Closures 原料,容器密封件管理●General requirements. 一般要求●Receipt and storage 接受和贮存●Testing and approval or rejection 检验和放行或拒绝放行●Use of approved 批准使用●Retesting of approved 批准复验●Production and Process Controls 生产和过程管理●Written procedures; deviations. 编写程序,偏差●Calculation of yield. 产量计算●Equipment identification. 设备鉴别●Sampling and testing of in-process materials and drug products. 成品和半成品取样检验●Time limitations on production. 产品时间限制●Control of microbiological contamination. 微生物污染管理●Reprocessing. 再制●Packaging and Labeling Control 包装和标签管理●Materials examination and usage criteria. 物料检验和使用标准●Labeling issuance. 标签保证●Packaging and labeling operations. 包装盒标签操作●Expiration dating. 有效期●Holding and Distribution 储存和分发●Warehousing procedures. 仓库程序●Distribution procedures. 发放程序●Laboratory Controls 实验室管理●Testing and release for distribution. 检验放行●Stability testing. 稳定性考察●Reserve samples. 留样●Records and Reports 记录和报告●Equipment cleaning and use log. 设备运行和清洁日志●Master production and control records. 主要生产和监控记录●Batch production and control records. 批生产监控记录●Production record review. 批记录检查●Complaint files. 投诉文件●Returned drug products. 退回产品●Drug product salvaging. 产品召回●The definitions and interpretations 定义和解释●Automatic, mechanical, and electronic equipment. 自动,电子机械设备●Lot number批号●Charge-in of components 控制原料●authorized personnel 被授权人员●outdated labels 过期标签cut labeling 裁切标签imprint labeling盖章标签●discrepancies不附和之处●excess labeling bearing lot 剩余的标签●更衣室Changing Room●一更First Changing Room●手消室Hands Disinfection Room●气闸室Airlock Room●洁具室Cleaning Tools Room●清洗室Cleaning Room●模具室Dies Room●内包装室Immediate Package Room●安全门Emergency Door●外包清室Outer Package Removing Room●存料间Storage Room of Raw Materials●粉碎室Pulverizing Room●备料室Materials Preparing Room●硬胶室Hard Capsules Filling Room●软胶室Soft Capsules Room●制粒干燥室Granulating and Drying Room●总混间Blending Room●中间站Intermediate Station●压片室Tablets Room Compression Room●包衣室Coating Room●配浆间Coating Mixture Preparing Room●铝塑包装间Packing Room●传递窗Transferring Window●外包装室Outer Packing Room●蒸馏水室Water Purifying Room●质检室Quality Control Room●浓配室Concentrated Solution Room●冻干机房Lyophilizer Room●暂存室Temporary Keeping●精制干燥室Purification & Drying●洁净洗衣室Clean Laundry●外清室Unpacking●洗瓶室Vials Washing Room●称量室Weighing●废物暂存室Waste●走廊Corridor●配制室Preparation●过滤室Filtration●灌装室Filling●包装室Packaging●成品待验室Quarantine●空调机房HV AC●常用动词:●set forth 符合●contain 包含●assure 确保●meets the requirements 符合标准●comply with 按照●is responsible for 负责●shall be subject to regulatory 遵守规章●furnish 配备●In lieu of such testing 代替这些检验●the oldest approved stock is used first 先入先出●visual inspection目检●Strict control 严格控制●Draft review approve起草,审核,批准●Determinat 测定标准句型Ragulations:1.If a person engages in only some operations subject to the regulations,that person need only complywith those regulations applicable to the operations in which he is engaged.按规程从事操作的员工必须按照他所从事的适合操作的规程操作2.Drug product means a finished dosage form, for example, tablet, capsule, solution, etc., that containsan active drug ingredient generally, but not necessarily, in association with inactive ingredients.药品意思是一个最终的剂型,如:片剂,胶囊剂,溶液剂等。
翻译美国FDA 《调查工作手册》中所遇到的缩略词(2012-04-09 10:13:58)转载▼分类:小百科标签:英语翻译fda调查工作手册缩略词最近,在忙一件翻译任务,翻译美国FDA的《调查工作手册》中的某些章节。
由于时间紧,任务重,以至于俺每晚都翻译到十一点,有天晚上甚至翻到半夜两点半(当然,主要是为了看半夜两点四十五分的欧冠联赛,呵呵。
但也因此肩膀酸痛,可能是肩周炎了,)。
在翻译过程中,遇到不少缩略词和缩写词。
其中有些在网上可以查到,有些则没有,需要联系上下文自行揣摩翻译。
现把俺自己的整理出来的缩略词表附上,以备不时之需。
ACRA:Associate Commissioner for Regulatory Affairs:日常事务办公室副主任AO:Administrative Officer:政务主任AOAC:Association of Official Analytical Chemists:美国公职分析化学家协会ASCII:American Standard Code for Informaition Interchange:美国信息交换标准码ATSDR:Agency for Toxic Substances and Disease Registry:有毒物质与疾病登记局BIMO:Bioresearch Monitoring:生物研究监测BSE:Bovine Spongiform Encephalopathy:疯牛病BTA:Bioterrorism Preparedness & Response Act:生物恐怖预防和应对法案CBER:Center for Biologics Evaluation & Research:生物制品评估研究中心CD-R:Compact Disk Recordable:CD盘CDER:Center for Drugs Evaluation & Research:药品评估研究中心CDRH:Center for Devices & Radiological Health:设备与放射卫生中心CFN:Central File Number:中心档案号CFP:Conference for Food Rrotection:食品保护协会CFR:Code of Federal Regulations:联邦法规法典CFSAN:Center for Food Safety & Applied Nutrition:食品安全和应用营养中心CGMP:Current Good Manufacturing Practice:动态药品生产管理规范CONUS:Continental United States:美国本土COPE:Coordinated Operations Plan for Emergencies:紧急情况协调行动计划CPG:Compliance Policy Guide:执行政策指南CPGM:Compliance Program Guidance Manual:执行项目指导手册C/R(CR):Collection Report:取样报告CTP:Center for Tobacco Products:烟草制品中心CVM:Center for Veterinary Medicine:兽药中心DCIA:Division of Small Manufacturers,Consumer & International Affairs:小型企业、消费者和国际事务部DCIQA:Division Compliance Information and Quality Assurance:执行信息与质量保证部DCMO:Division of Compliance Management & Operations:执行管理行动部DCP:Division of Compliance Policy:执行政策部DD:District Director:地区主管DDFI:Division of Domestic Field Investigations:国内实地调查部DFFI:Division of Foreign Field Investigations:国外实地调查部DFOI:Division of Freedom of Information:信息自由部DFS:Division of Field Science:外勤科技部DFSR:Division of Federal-State Relations:与联邦-州关系部DHHS:Department of Health & Human Services:美国卫生与公共服务部DHRD:Division of Human Resource Development:人力资源开发部DIOP:Division of Import Operations and Policy:进口行动与政策部DMO:Division of Management Operations:运营管理部DO:District Office:地区办公室DOC:Documentary or Official:文件正式样品DOD:Department of Defense:国防部DSMICA:Division of Manufacturers,International and Consumer Affairs:制造商、国际和消费者事务部DVM:Doctor of Veterinary Medicine:兽医学博士EI:Establishment Inspection:实施检查EIR:Establishment Inspection Report:检查实施报告EO:Ethylene Oxide Gas:氧化乙烯气体EOC:Emergency Operations Center:紧急行动中心EPA:Environmental Protection Agency:环保局EPIC:Egg Products Inspection Act:蛋制品检查法案ERC:Emergency Response Coordinator:紧急应对协调员FACTS:Field Accomplishments & Compliance Tracking System:外勤业绩与执行追踪系统FDA:Food & Drug Administration:美国食品与药品管理局FDA3369:Daily Log of Government Vehicle:政府车辆使用日志表FDA464:Collection Report(CR)(C/R):取样报告FDA482:Notice of Inspection:检查通知书FDA483:Inspectional Observations:检查观察通知书FDA484:Receipt for Samples:样品收据(表)FDAAA:Food & Drug Administration Amendments Act:食品与药品管理法修正案FDAMA:Food & Drug Administration Modernization Act:食品与药品管理现代化法案FD&C:Federal Food,Drug,and Cosmetic Act:联邦食品、药品与化妆品法案FEI:FDA Establishment Identifier:FDA注册识别号码FMD:Field Management Directive:外勤管理指令FOIA:Freedom of Information Act:信息自由法案FPS:Federal Protective Service:联邦保护局FR:Federal Register:联邦公报FSIS:Food Safety and Inspection Service:食品安全检验局FTR:Federal Travel Regulations:联邦旅行法规GCP:Good Clinical Practice:药品临床试验管理规范GGP:Good Guidance Practices:指导管理规范GIIT:Guide to International Inspections and Travel:国际检查和出差指导GLP:Good Laboratory Practice:良好实验室管理规范GMP:Good Manufacturing Practice:生产管理规范GOV:Government-Owned Vehicles:政府车辆GSA:General Services Administration:联邦政府总务管理局GSA-3155:Offense/Incident Report:过失/事故报告表GWQAP:Federal Medical Products Quality Assurance Program:联邦医疗产品质量保证项目HACCP: Hazard Analysis and Critical Conttol Point: 危害分析和关键控制点体系HBV:Hepatitis B Virus:乙肝病毒HFA-320:Division of Mnangement Programs:管理项目部HFA-615:Emergency Operations Center:紧急行动中心HFC-10:Office of Resource Management:资源管理办公室(ORM)HFC-100:Ofiice of Regional Operations:大区行动办公室(ORO)HFC-130:Division of Domestic Field Investigations:国内实地调查部(DDFI)HFC-140:Division of Field Science:外勤科技部(DFS)HFC-150:Division of Federal-State Relations:与联邦-州关系部(DFSR)HFC-170:Division of Import Operations and Policy:进口货物行动与政策部(DIOP)HFC-180:Prior Notice Center:预警中心(PNC)HFC-20:Division of Management Operations:运营管理部HFC-200:Office of Eenforcement:执行办公室(OE)HFC-230:Division of Complaince Policy:执行政策部(DCP)HFC-300:Office of Criminal Investigations:犯罪调查办公室(OCI)HFC-40:Division of Planning, Evalution and Management:规划、评估和管理部HFC-60:Division of Human Resource Development:人力资源发展部HFI-1:Assistant Commissioner for Public Affairs:公共事务办公室副主任HFI-35:Division of Freedom Information:信息自由部(DFOI)HFM-445:Division of Viral Products:病毒产品部HHS-481:Employee Claim For Loss or Damage to Personal Property:工作人员个人财产损失或损毁索赔书ICAM:International Cooperative Agreement Manual:国际合作协议手册ICH:International Conference On Harmonization:药品注射技术要求国际协调会IDM:Information Disclosure Manual:信息披露手册INV:Inventory Management:库存管理IOB:International Operations Branch:国际行动分部IOM:Investigation Operations Manual:调查工作手册ISSC:Interstate Shellfish Sanitation Conference:州际贝类卫生协会ITG:Inspection Technical Guide:检查技术指导LACF:Low Acid Canned Foods:低酸罐装食品LIB:Laboratory Information Bulletin:实验室信息通报LPM:Laboratory Procedures Manual:实验室流程手册M&IE:Meals and Incidental Expenses:食杂费MDUFMA:Medical Device user Fee & Modernization Act:医疗设备使用收费与现代化法案MDQS:Medical Device Quality System:医疗设备质量管理体系MOA:Ministry of Agriculture:农业部MOU:Memoranda of Understanding:谅解备忘录MPH:Master of Public Health:公共卫生学硕士MQSA:Mammography Quality Standard Act:乳腺X射线摄影质量标准法案MRA:Mutual Recognition Agreement:相互承认协议MSDS:Material Safety Data Sheets:原料安全数据板NCIMS:National Conference on Interstate Milk Shipments:州际奶品贸易全国协会NDA:New Drug Application:新药申请规范NDA:Non-Discloure Agreement:保密协议NIST:National Institute of Standards & Technology:国家标准技术研究所NTEU:National Treasury Employees Union:国家财政员工工会NTIS:National Technical Information Service:国家技术情报服务处OA:Office of Administration:行政办公室OASIS:Operational and Administrative System for Import Support:支持进口运作和管理系统OBA:Oxygen Breathing Apparatus:氧气呼吸器OC:Office of Commisioners:主任办公室OCC:Office of Chief Counsel:首席律师办公室OCI:Office of Criminal Investigations:犯罪调查办公室OE:Office of Enforcement:执行办公室OEI:Official Establishment Inventory:单位正式注册清单OFM:Office of Financial Management:财务管理办公室OFS:Office of Financial Services:财务服务办公室OIA:Office of Internal Affairs:内务办公室OIM:Office of Information Management:信息管理办公室ORA:Office of Regulatory Affairs:日常事务办公室ORM:Office of Resource Management:资源管理办公室ORO:Office of Regional Operations:大区行动办公室OS:Official Sample:法定样品OSHA:Occupational Safety & Health Administration:职业安全卫生管理局PAC:Program Assignment Code:任务程序代码PAIRS:Public Affairs Reporting System:公共事务报告系统PAS:Public Affairs Specialist:公共事务专家PAT:Process Analytical Technology:加工分析技术规范PEL:Permissible Exposure Limit:允许暴露限制规定PHS:Public Health Services Act:公共卫生服务法案PMA:Pre-Market:上市之前PNC:Prior Notice Center:预警中心POC:Point of Contact:联系点POV:Privately Owned Vehicle:私家车PPIA:Poultry Products Inspection Act:禽类制品检查法案PSC:Program Support Center:项目支援中心QMS:Quality Management System:质量管理系统RFDD:Regional Food & Drug Director:大区食品与药品管理局局长RFR:Reportable Food Registry:可疑食品注册RMP:Regulatory Procedures Manual:管理流程手册SAFES:State Advisory Fax/Email System:国家传真/电子邮件报告系统SBR:Small Business Representative:大区小型公司代理员SBREFA:Small Business Regulatory Enforcement Fairness Act:小型公司监管和执法公平法案SCBA:Self-Contained Breathing Apparatus:自主式呼吸器SF-91:Motor Vehicle Accident Report:机动车辆事故报告书SF-94:Statement of Witness:目击报告SF-95:Claim for Damage,Injury or Death:对损毁、受伤或死亡的索赔书SMG:Staff Manual Guide:员工手册指南SOP:Standard Operation Procedures:标准操作(作战)程序(规范)(规定)SQL:Structured Query Language:结构化查询语言SSN:Social Security Number:社会保险号TA:Travel Authorization:出差批准书TMC:Travel Management Center:旅行管理中心UFMS:Unified Financial Management System:联合财务管理系统U.S.C.:United States Code:美国法典USP:United States Pharmacopoeia Convention:美国药典公约VWA:Voluntary Work Agreement:志愿工作协议WEAC:Winchester Engineering & Analytical Center:温彻斯特工程分析中心。
检验报告 Certificate of analysis化工有限公司chemical CO. , LTD制药(药业)有限公司Pharmaceutical co. ,Ltd.化工厂CHEMICAL PLANT精细化工有限公司FINE CHEMICAL CO., LTD品名PRODUCT //title批号batch NO.生产日期manufacturing date // manu. Date检验日期Analysis date有效期Exp date // expiry date检验标准quality standard //inspecting basis //Specification数量QUANTITY 报告日期report date 包装规格package企业标准Company Standard//enterprise standard检查项目test items//analytical items性状appearance // characteristics//description//Character分子式molecular formula 分子量molecular wt化学式Chemical formula鉴别identification溶液外观appearance of solution澄清度&颜色clarity & color白色或类白色结晶粉末white or almost white crystalline powder味微苦 a little bitter taste无色无味odorless,smelless酸碱度acidity and alkalinity铅盐Plumbum salts 砷盐Arsonium salts有关物质related substances 分为:individual impurity substance NMT….;total impurity substance NMT。
干燥失重loss on drying炽灼残渣residue on ignition重金属heavy metals溶剂残留solvent residue有机挥发性物质organic volatile impurities溶解度solubility熔点melting point旋光度optical rotation灰分sulphated ash水分water content //moisture粒度particles size //MESHSIZEPH值PH Value吸收系数absorption coefficient氯化物chloride 硫酸盐sulphate农药残留residue of pesticide微生物限度细菌Microbial Limit bacteria细菌总数total plate count霉菌和酵母菌yeast & mold //Mildew&Microzyme大肠杆菌E.coil//Esherichia coli沙门氏菌salmonella含量ASSAY按归一法计算Calculated on the Normalization method按干燥品计算Calculated on the anhydrous substance应符合规定complies with the CRS //meet the requirements不少于no less than 不多于no more than //NMT无negative 有positive欧洲药典EurPh美国USP中国CH. P ***J.P80-100目80-100mesh澄清无色clear and colorless紫外灯Ultraviolet ray lamp溶于soluble in ..易溶于freely soluble in.. 微溶于sparing soluble in ..与对照品图谱一致Corresponding to Reference Spectrum结果results符合规定conforms // complies with // pass //meet the requirement结论CONCLUSION符合英国药典2000版complieswith BP 2000化验员Analyst 复核员Checker 质保经理QAmanager // QA director检验报告 Certificate of analysis -经常用其缩写COA企业标准Company Standard//enterprise standard -有时也可用internal standard(比如药品生产厂检验某个辅料时用的是企业自己定的标准,也就是内部标准。
)性状appearance // characteristics//description//Character -在药品检验里,appearance (外观)是包括在description(性状)里的。
appearance是指颜色、形状、臭、味等,description 还包括熔点、溶解度等。
白色或类白色结晶粉末white or almost white crystalline powder -类白色也经常用off white这个词有关物质related substances 分为:individual impurity substance NMT….;total impurity substance NMT。
-individual impurity substance是指已知的单一杂质,unknown impurities是指未知杂质,两者加起来是total impurity(总杂质)。
NMT是not morethan的缩写,是杂质限度。
干燥失重loss on drying -缩写LOD有机挥发性物质organic volatile impurities -经常用其缩写OVIs灰分sulphated ash -灰分通常是指总灰分,包括水溶性灰分、水不溶性灰分、酸溶性灰分、酸不溶性灰分。
sulphated ash是指硫酸盐灰分,也就是炽灼残渣ELISA enzyme-linked immunosorbent assay 酶联免疫吸附分析ESI electrospray ionization 电喷雾电离ESR electron spin resonance 电子自旋共振(顺磁共振)FAB fast atome bombardment 快原子轰击FI(A) flow injection (analysis) 流动注射(分析)FID flame ionization detection(detector) 火焰电离检测(器)Fig figure 表FITC fluorescein isothiocyannate 异硫氰荧光素FT Fourier transform 傅立叶变换GC gas chromatography(ic);glassy carbon 气体色谱;玻璃碳GCE glassy carbon electrode 玻碳电极GF graphite furnace 石墨炉GPC gel permeation chromatography(ic) 凝胶渗透色谱法(的)HPGC high performance gas chromatography(ic) 高效气相色谱(的)HPLC high performance liquid chromatography(ic) 高效液体色谱(的)HSA human serum albumin 人血清白蛋白IC ion chromatography(ic) 离子色谱(的)ICP inductively coupled plasma 电感耦合等离子体Ig(G) immunoglobulin(G) 免疫球蛋白(G)IR infrared(rediation) 红外(辐射)ISE ion selective electrode 离子选择电极lab laboratory 实验室LC liquid chromatography(-ic) 液体色谱(的)LOD limit of detection 检测限m/z mass-to-charge ratio 质荷比MALDI matrix-assisted laser desorption/ionization 基质辅助激光解吸/电离MIP microwave-induced plasma;molecular imprinted polymer 微波诱导等离子体;分子印迹聚合物MLR multiple linear regression 多元线性回归mp melting point 熔点MRM multiple reaction monitoring 多反应监测MS mass spectrometry(ic) 质谱(的)MS-MS tandem mass spectrometry(-ic) 串联质谱(的)MW molecular weight 相对分子质量μ-TAS miniaturized total analysis system 微全分析系统NAA neutron activation analysis 中子活化分析NIR near infrared(radiation) 近红外(辐射)NMR nuclear magnetic resonance(spectrometry) 核磁共振(光谱)(MW)(C)NT (multi-walled)(carbon) nanotube (多壁)(碳)纳米管PAGE polyacrylate gel electrophoresis 聚丙烯酰胺凝胶电泳PBS phosphate buffer solution 磷酸盐缓冲溶液PCA principal component analysis 主成分分析PCR polymerase chain reaction; principal component regression 聚合酶链式反应;主成分回归PLS partial least squares 偏最小二乘法PMT photomultiplier tube 光电倍增管PRESS predictive residual error sum of squares 预报残差平方和resoln,(RS)resolution 分辨,分离度,分辨率RMSE root mean square error 均方根误差RNA ribonucleic acid 核糖核酸RSD relative standard deviation 相对标准偏差RT retention time 保留时间SCE standard calomel electeode 标准甘汞电极SD standard diviation 标准偏差SDBS sodium dodecylbenzene sulfonate 十二烷基苯磺酸钠SDS sodium dodecylsulfonate 十二烷基磺酸钠SEC size exclusion chromatography(-ic) 体积排阻色谱(的)SEM scanning electron microscopy(-ic); secondary electron multiplier 扫描电子显微镜(的);次级电子倍增器SFC supercritical fluid chromatography(-ic) 超临界流体色谱(的)SIM selected ion monitoring 选择性离子监测SPE solid phase extraction 固相萃取SPME solid phase microextraction 固相微萃取STM scanning tunneling microscopy(-ic) 扫描隧道显微镜(的)TEM transmission electron microscopy(-ic) 透射电子显微镜(的)TGA thermogravimetry analysis 热重分析TIC total ion chromatogram 总离子流色谱图TIMS thermo-ionization mass spectrometry(-ic) 热电离质谱(的)titrn titration 滴定TLC thin-layer chromatography(-ic) 薄层色谱(的)UV ultraviolet (radiation) 紫外(辐射)VIS visible(radiation) 可见(辐射)wt weight 重量XPS X-ray photoelectron spectrometry(-ic) X-射线光电子能谱(的)XRD X-ray diffraction X-射线衍射XRF X-ray fluorescence(spectrometry(-ic)) X-线荧光(光谱(的))。