FDA英语术语大全
FDA术语词汇全
防撬包装[Top] [Laws & Regulations] [FDA Organization] [SFDA][Top] [Laws & Regulations] [FDA Organization] [SFDA]FDA Organization Charts[Top] [Laws & Regulations] [FDA Organization] [SFDA][Top] [Laws & Regulations] [FDA Organization] [SFDA]1 of the Bureau of Customs and Border Protection (CBP)2 a biologic response modifier, is a single-chain polypeptide containing 140 amino acids3 An unwanted effect caused by the administration of drugs. Onset may be sudden or develop over time4 Organizations and groups that actively support participants and their families with valuable resources, including self-empowerment and survival tools.5 A negative experience encountered by an individual during the course of a clinical trial that is associated with the drug.6The basic premise of AIP is: If FDA determines that a company’s applications are not reliable, the agency will not perform su bstantive review of any of the company’s applications until confidence in the data is restored.7 An alanine aminotransferase (ALT) test measures the amount of this enzyme in the blood. ALT is measured to see if the liver is damaged or diseased.8 to check for liver disease or damage to the liver. Symptoms of liver disease can include jaundice, belly pain, nausea, and vomiting. An ALP test may also be used to check the liver when medicines that can damage the liver are taken or to check bone problems (sometimes found on X-rays), such as rickets, osteomalacia, bone tumors, Paget's disease, or too much of the hormone that controls bone growth (parathyroid hormone).9 An allograft is a transplanted organ or tissue from a genetically non-identical member of the same species10 is a general linear model with a continuous outcome variable (quantitative) and two or more predictor variables where at least one is continuous (quantitative) and at least one is categorical (qualitative). ANCOVA is a merger of ANOVA and regression for continuous variables. ANCOVA tests whether certain factors have an effect on the outcome variable after removing the variance for which quantitative predictors (covariates) account. The inclusion of covariates can increase statistical power because it accounts for some of the variability11 Any of the treatment groups in a randomized trial.12 Low levels of AST are normally found in the blood. When body tissue or an organ such as the heart or liver is diseased or damaged, additional AST is released into the bloodstream. The amount of AST in the blood is directly related to the extent of the tissue damage.13 A renewable permit granted by the federal government to an institution or research center to conduct clinical trials.14 in an "as treated" (or "observed data") analysis only those patients still taking the assigned treatment are analyzed; those who drop out are "censored."15指由不直接涉及试验的人员所进行的一种系统性检查，以评价试验的实施、数据的记录和分析是否与试验方案、标准操作规程以及药物临床试验相关法规要求相符16一种批准用于治疗2型糖尿病的药物17 Benzodiazepines have also been used as a "date rape" drug because they can markedly impair and even abolish functions that normally allowa person to resist or even want to resist sexual aggression or assault18本类药物也称弱安定药，包括氯氮卓(利眠宁，chlordiazepoxide，商品名Librium)、地西泮(安定，diazepam，商品名valium)、硝西泮(硝基安定，nitrazepam)、氟西泮(氟安定，flurazepam)及奥沙西泮(去甲羟基安定，舒宁，oxazepam)。
FDA_GMP_ICH临床实验专业英语词汇互译
FDA常用词中英对照FDA(food and drug adminisration)：(美国)食品药品监督管理局NDA(new drug application)：新药申请ANDA(abbreviated new drug application)：简化新药申请EP(export application)：出口药申请(申请出口不被批准在美国销售的药品)treatment IND：研究中的新药用于治疗abbreviated(new)drug：简化申请的新药DMF(drug master file)：药物主文件(持有者为谨慎起见而准备的保密资料,可以包括一个或多个人用药物在制备,加工,包装和贮存过程中所涉及的设备,生产过程或物品.只有在DMF持有者或授权代表以授权书的形式授权给FDA,FDA在审查IND, NDA,ANDA时才能参考其内容)holder：DMF持有者CFR(code of federal regulation)：(美国)联邦法规PANEL：专家小组batch production：批量生产;分批生产batch production records：生产批号记录post or pre-market surveillance：销售前或销售后监督informed consent：知情同意(患者对治疗或受试者对医疗试验了解后表示同意接受治疗或试验)prescription drug：处方药OTC drug(over—the—counter drug)：非处方药U.S. public health service：美国卫生福利部NIH(national institute of health)：(美国)全国卫生研究所animal trail：动物试验accelerated approval：加速批准standard drug：标准药物investigator ：研究人员;调研人员preparing and submitting：起草和申报submission：申报;递交benefit(s)：受益risk(s)：受害drug product：药物产品drug substance：原料药established name：确定的名称generic name：非专利名称proprietary name：专有名称;INN(international nonproprietary name)：国际非专有名称narrative summary：记叙体概要adverse effect：副作用adverse reaction：不良反应protocol：方案archival copy：存档用副本review copy：审查用副本official compendium：法定药典(主要指USP, NF).USP(the united state pharmacopeia)：美国药典(现已和NF合并一起出版)NF(national formulary)：(美国)国家药品集official=pharmacopeial = compendial：药典的;法定的;官方的agency：审理部门(指FDA)sponsor：主办者(指负责并着手临床研究者)identity：真伪;鉴别;特性strength：规格;规格含量(每一剂量单位所含有效成分的量)labeled amount：标示量regulatory specification：质量管理规格标准(NDA提供)regulatory methodology：质量管理方法(FDA用于考核原料药或药物产品是否符合批准了的质量管理规格标准的整套步骤)regulatory methods validation：管理用分析方法的验证(FDA对NDA提供的方法进行验证) Dietary supplement：食用补充品ICH(International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)人用药物注册技术要求国际协调会议ICH：Quality-质量Q1A(R2)：Stability Testing of New Drug Substances and Products (Second Revision)新原料药和制剂的稳定性试验(第二版)Q1B：Photostability Testing of New Drug Substances and Products新原料药和制剂的光稳定性试验Q1C：Stability Testing for New Dosage Forms新制剂的稳定性试验Q1D：Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products原料药和制剂稳定性试验的交叉和矩阵设计Q1E：Evaluation of Stability Data对稳定性数据的评估处理Q1F：Stability Data Package for Registration Applications in Climatic Zones III and IV在气候带III和IV,药物注册申请所提供的稳定性数据Q2A：Text on Validation of Analytical Procedures分析程序的验证Q2B：Validation of Analytical Procedures：Methodology分析程序的验证：方法学Q3A(R)：Impurities in New Drug Substances (Revised Guideline)新原料药中的杂质(修订版)Q3B(R)：Impurities in New Drug Products (Revised Guideline)新制剂中的杂质(修订版)Q3C：Impurities：Guideline for Residual Solvents杂质：残留溶剂指南Q3C(M)：Impurities：Guideline for Residual Solvents (Maintenance)杂质：残留溶剂指南(修改内容)Q4：Pharmacopoeias药典Q4A：Pharmacopoeial Harmonisation 药典的协调Q4B：Regulatory Acceptance of Pharmacopoeial Interchangeability药典互替在法规上的可接受性Q5A：Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin来源于人或者动物细胞系的生物技术产品的病毒安全性评估Q5B：Quality of Biotechnological Products：Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products生物技术产品的质量：源于重组DNA的蛋白质产品的生产中所用的细胞中的表达构建分析Q5C：Quality of Biotechnological Products：Stability Testing of Biotechnological/Biological Products生物技术产品的质量：生物技术/生物产品的稳定性试验Q5D：Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products用于生产生物技术/生物产品的细胞底物的起源和特征描述Q5E：Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process基于不同生产工艺的生物技术产品/生物产品的可比较性Q6：Specifications for New Drug Substances and Products新原料药和制剂的质量规格Q6A：Specifications：Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products：Chemical Substances质量规格：新原料药和新制剂的检验程序和可接收标准：化学物质Q6B：Specifications：Test Procedures and Acceptance Criteria for Biotechnological/Biological Products质量规格：生物技术/生物产品的检验程序和可接收标准Q7：Good Manufacturing Practices for Pharmaceutical Ingredients活性药物成份的GMPQ7A：Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients活性药物成份的GMP指南Q8：Pharmaceutical Development药物研发Q9：Quality Risk Management质量风险管理ICH：Safety-安全S1A：Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals药物致癌性研究需要的指南S1B：Testing for Carcinogenicity of Pharmaceuticals药物致癌性的检验S1C：Dose Selection for Carcinogenicity Studies of Pharmaceuticals药物致癌性研究之剂量选择S1C(R)：Addendum：Addition of a Limit Dose and Related Notes附录：极限剂量和有关注释的的补充S2A：Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals受法规管辖的药物基因毒性检验的特定方面的指南S2B：Genotoxicity：A Standard Battery for Genotoxicity Testing for Pharmaceuticals基因毒性：药物基因毒性检验的标准S3A：Note for Guidance on Toxicokinetics：The Assessment of Systemic Exposure in Toxicity Studies毒物代谢动力学指南的注释：毒性研究中的全身性暴露量的评估S3B：Pharmacokinetics：Guidance for Repeated Dose Tissue Distribution Studies药物代谢动力学：重复剂量的组织分布研究指南S4：Single Dose Toxicity Tests单剂量毒性检验S4A：Duration of Chronic Toxicity Testing in Animals (Rodent and Non-Rodent Toxicity Testing)动物体内慢性毒性持续时间的检验(啮齿动物和非啮齿动物毒性检验)S5A：Detection of Toxicity to Reproduction for Medicinal Products药物对生殖发育的毒性的检验S5B(M)：Maintenance of the ICH Guideline on Toxicity to Male Fertility：An Addendum to the Guideline on Detection of Toxicity to Reproduction for Medicinal Products对男性生殖能力的毒性的指南的变动：药物对生殖发育的毒性的检验指南增加了一个附录S6：Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals生物技术生产的药物的临床前安全评价S7A：Safety Pharmacology Studies for Human Pharmaceuticals人用药的安全药理学研究S7B：The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization(QT Interval Prolongation) By Human Pharmaceuticals药物延迟心室复极化(QT间期)潜在作用的非临床评价S8：Immunotoxicology Studies for Human Pharmaceuticals人用药免疫毒理学研究M3(M)：Maintenance of the ICH Guideline on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals药物的对人临床试验的非临床安全研究指南的变动E-Efficacy(有效)E1：The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions对用于无生命危险情况下长期治疗的药物进行临床安全评估的族群暴露量范围E2A：Clinical Safety Data Management：Definitions and Standards for Expedited Reporting 临床安全数据管理：速报制度的定义和标准E2B(R)：Revision of the E2B(M) ICH Guideline on Clinical Safety Data Management Data Elements for Transmission of Individual Case Safety Reports个案安全报告送交的临床安全数据管理的数据要素指南(E2B(M))的修订版E2B (M)：Maintenance of the Clinical Safety Data Management including：Data Elements for Transmission of Individual Case Safety Reports临床安全数据管理的变动包括：个案安全报告送交的数据要素E2B(M)：Maintenance of the Clinical Safety Data Management including Questions andAnswers临床安全数据管理的变动,包括问答E2C：Clinical Safety Data Management：Periodic Safety Update Reports for Marketed Drugs 临床安全数据管理：已上市药品的周期性安全数据更新报告Addendum to E2C：Periodic Safety Update Reports for Marketed DrugsE2C的附录：已上市药品的周期性安全数据更新报告E2D：Post-Approval Safety Data Management：Definitions and Standards for Expedited Reporting批准后的安全数据管理：速报制度的定义和标准E2E：Pharmacovigilance Planning药物警戒计划E3：Structure and Content of Clinical Study Reports临床研究报告的结构和内容E4：Dose-Response Information to Support Drug Registration支持药品注册的剂量-效应资料E5：Ethnic Factors in the Acceptability of Foreign Clinical Data引入海外临床数据时要考虑的人种因素E6：Good Clinical Practice：Consolidated GuidelineGCP：良好的临床规范：统一的指南E7：Studies in Support of Special Populations：Geriatrics对特定族群的支持的研究：老人病学E8：General Considerations for Clinical Trials对临床试验的总的考虑E9：Statistical Principles for Clinical Trials临床试验的统计原则E10：Choice of Control Group and Related Issues in Clinical Trials临床试验中控制组和有关课题的选择E11：Clinical Investigation of Medicinal Products in the Pediatric Population小儿科药物的临床调查E12A：Principles for Clinical Evaluation of New Antihypertensive Drugs新抗高血压药物的临床评价原则E14：The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs非抗心率失常药物的QT/QTc 间期和致心率失常潜在作用的临床评价Multidisciplinary Guidelines 多学科兼容的指南M1：Medical Terminology医学术语M2：Electronic Standards for Transmission of Regulatory Information (ESTRI)药政信息传递之电子标准M3：Timing of Pre-clinical Studies in Relation to Clinical Trials (See Safety Topics)有关临床试验的临床前研究的时间安排M4：The Common Technical Document (See CTD section for complete Status of the guidelines) 通用技术文件(见有关CTD章节)M5：Data Elements and Standards for Drug Dictionaries药物词典的数据要素和标准临床试验常用的英文缩略语TTP：time-to-progression 疾病进展时间SAE：severity Adverse Event 严重不良事件AE：Adverse Event 不良事件SOP：Standard Operating Procedure 标准操作规程CRF：Case Report form 病例报告表DLT：剂量限制毒性MTD：最大耐受剂量KPS：Karnofsky Performance Status行为状态评分CR：complete response完全缓解PR：partial response部分缓解SD：病情稳定PD：progressive disease病情进展CTC：常用药物毒性标准IEC：independent ethics committee 独立伦理委员会IRB ：institutional review board 伦理委员会CRA：临床研究助理CRO：Contract Research Organization 合同研究组织DFS：Disease Free Survival 无病生存期OS：(Overall Survival) 总生存时间IC：Informed consent 知情同意ADR：Adverse Drug Reaction 不良反应GAP：Good Agricultural Practice 中药材种植管理规范GCP：Good Clinical Practice 药物临床试验质量管理规范GLP：Good Laboratory Practice 药品实验室管理规范GMP：Good Manufacturing Practice 药品生产质量管理规范GSP：Good Supply Practice 药品经营质量管理规范GUP：Good Use Practice 药品使用质量管理规范PI ：Principal investigator 主要研究者CI：Co-inveatigator 合作研究者SI ：Sub-investigator 助理研究者COI ：Coordinating investigtor 协调研究者DGMP：医疗器械生产质量管理规范ICF：Informed consent form 知情同意书RCT ：randomized controlled trial, 随机对照试验NRCCT：non-randomized concurrent controlled trial, 非随机同期对照试验EBM：evidence-based medicine 循证医学RCD：randomized cross-over disgn 随机交叉对照试验HCT：historial control trial, 历史对照研究RECIST：Response Evaluation Criteria In Solid Tumors. 实体瘤疗效反应的评价标准QC：Quality Control质量控制UADR：Unexpected Adverse Drug Reaction,非预期药物不良反应GMP英语PIC/S的全称为：Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme, PIC/S(制药检查草案), 药品检查协会(PIC/S) ,也有人称PIC/S为医药审查会议/合作计划(PIC/S)PIC的权威翻译：药品生产检查相互承认公约API(Active Pharmaceutical Ingrediet) 原料药又称：活性药物组分AirLock 气闸Authorized Person 授权人Batch/Lot 批次Batch Number/Lot-Number 批号;Batch Numbering System 批次编码系统;Batch Records 批记录;Bulk Product 待包装品;Calibration 校正;Clean area洁净区;Consignmecnt(Delivery)托销药品.ABPI Association of the British Pharmaceutical IndustryADR Adverse Drug ReactionAE Adverse EventAIM Active Ingredient ManufacturerANDA Abbreviated New Drug ApplicationANOVA Analysis of VarianceASM：Active Substance ManufacturerATC Anatomical Therapeutic ChemicalATX Animal Test Exemption CertificateBANBritish Approved NameBIRABritish Institute of Regulatory AffairsBNF British National FormularyBP British PharmacopoeiaC of A Certificate of AnalysisC of S Certificate of SuitabilityCENTRE FOR DRUG EVALUATION (CDE)Centre for Pharmaceutical Administration (CPA)CMS Concerned Member StateCMS每个成员国COS Certificate of SuitabilityCPMP Committee for Proprietary Medicinal ProductsCRA Clinical Research AssociateCRF Case Report FormCRO Contract Research OrganisationCTA Clinical Trial ApplicationCTC Clinical Trial CertificateCTD Common Technical DocumentCTX Clinical Trials ExemptionDDD Defined Daily DoseDGC Daily Global ComparisonDIA Drug Information AssociationDMF Drug Master FileDrug Registration Branch (DR, Product Evaluation & Registration Division, CPAEDQM (European Directorate for the Quality of Medicines) 欧洲联盟药品质量指导委员会EEA 欧洲经济地区EGMA European Generics Medicine AssociationELA Established Licence ApplicationEMEA European Medicines Evaluation AgencyEMEA (European Agency for the Evaluation of Medicinal Products) 欧洲联盟药品评价机构EP European PharmacopoeiaEPAR European Public Assessment ReportsESRA European Society of Regulatory AffairsEuropean Pharmacopoeia Commission 欧洲药典委员会FDA Food and Drug Administrationfinal evaluation report (FER)free sale certificates (FSCs)Health Sciences Authority (HSA)HSA's Medicines Advisory Committee (MAC)IB Investigators BrochureICH International Conference for HarmonisationIDMC Independent Data-Monitoring CommitteeIEC Independent Ethics CommitteeIND Investigational New DrugINN International Non-proprietary NameInternational Conference on Harmonisation (ICH)IPC In Process ControlIRB Institutional Review BoardLICENCE HOLDERMA Marketing AuthorisationMAA Marketing Authorisation ApplicationMAA上市申请MAH Marketing Authorisation HolderMAH 销售许可持有者MCA Medicines Control AgencyMHW Ministry of Health and Welfare (Japan)MR Mutual RecognitionMRA 美国与欧盟的互认协议MRAs (Mutual Recognition Agreements) 互相认证同意MRFG Mutual Recognition Facilitation GroupMRPMutual Recognition ProcedureNASNew Active SubstanceNCENew Chemical EntityNDANew Drug Applicationnew chemical entities (NCEs)new drug applications (NDAs)NSAID Non Steroidal Anti Inflammatory DrugNTA Notice To ApplicantsOOS Out of SpecificationOTC Over The CounterPAGB Proprietary Association of Great BritainPh Eur European PharmacopoeiaPIL Patient Information LeafletPL Product LicencePOM Prescription Only MedicinePRODUCT OWNERPSU Periodic Safety UpdatesQA Quality AssuranceQC Quality ControlRAJ Regulatory Affairs JournalRMS Reference Member StateRMS相互认可另一成员国RSD Relative Standard DeviationRx Prescription OnlySAE Serious Adverse EventSMF Site Master FileSOP Standard Operating ProcedureSOP (STANDARD OPERATION PROCEDURE) 标准运作程序SPC/SmPC Summary of Product Characteristicssummary of product characteristics(SPC)Therapeutic Goods Administration (TGA)USP US PharmacopoeiaVMF Veterinary Master FileVPC Veterinary Products CommitteeA.A.A Addition and Amendments 增补和修订AC Air Conditioner 空调器ADR Adverse Drug Reaction 药物不良反应AFDO Association of Food and Drug Officials 食品与药品官员协会(美国) ACC Accept 接受AQL Acceptable Quality Level 合格质量标准ADNA Abbreviated New Drug Application 简化的新药申请BOM Bill of Material 物料清单BPC Bulk pharmaceutical Chemiclls 原料药CBER Center for Biologics Evaluation Research 生物制品评价与研究中心CFU Colony Forming Unet 菌落形成单位DMF Drug Master File 药品管理档案CDER Cemter for Drug Evaluation amd Research 药物评价与研究中心CI Corporate Identity (Image) 企业识别(形象)CIP Cleaning in Place 在线清洗CSI Consumer Safety Insepctor 消费者安全调查员CLP Cleaning Line Procedure 在线清洗程序DAL Defect Action Level 缺陷作用水平DEA Drug Enforcement Adminestration 管制药品管理DS Documentation Systim 文件系统FDA Food and Drug Administration 食品与药品管理局(美国)GATT General Agreemernt on Tariffs and Trade 关贸总协会GMP Good Manufacturing Practice Gvp 药品生质量管理规范GCP Good Clinical Practice 药品临床实验管理规范GLP Good Laboratory Practice 实验室管理规范GSP Good Supply Practice 药品商业质量规范GRP Gook RaTAIL Practice 药品零业质量管理规范GAP Good Agriculture Practice 药材生产管理规范GVP Gook Validation Prctice 验证管理规范GUP Gook Use Practice 药品重用规范HVAC Heating Ventilation Air Conditioning 空调净化系统ISO Intematonal Organization for Standardization 车际标准化组织MOU Memorandum of Understanding 谅解备忘录PF Porduction File 生产记录用表格OTC Over the Counter (Drug) 非处方药品PLA Product License Application 产品许可申请QA Quality Assurance 质量保证QC Quality Control 质量控制QMP Quality Management Procedure 质量管理程序SDA State Drug Administration 国家药品监督管理局SMP Standard Managmert Procedure 标准管理程序SOP Standard Operating Procedure 标准操作程序TQC Tatal Quality Control 全面质量管理USA Uneted States Pharmacopeia 美国药典ICH 安全性领域常用专业术语中英文对照表Dead offspring at birth 出生时死亡的子代Degradation 降解Delay of parturition 分娩延迟Deletion 缺失Descriptive statistics 描述性统计Distribution 分布Detection of bacterial mutagen 细菌诱变剂检测Detection of clastogen 染色体断裂剂检测Determination of metabolites 测定代谢产物Development of the offspring 子代发育Developmental toxicity 发育毒性Diminution of the background lawn 背景减少Direct genetic damage 直接遗传损伤DNA adduct DNA加合物DNA damage DNA损伤DNA repair DNA修复DNA strand breaks DNA链断裂Dose escalation 剂量递增Dose dependence 剂量依赖关系Dose level 剂量水平Dose-limiting toxicity 剂量限制性毒性Dose-raging studies 剂量范围研究Dose-relatived mutagenicity 剂量相关性诱变性Dose-related 剂量相关Dose-relatived cytotoxicity 剂量相关性细胞毒性Dose-relatived genotoxic activity 剂量相关性遗传毒性Dose-response curve 剂量-反应曲线Dosing route 给药途径Duration 周期Duration of pregnancy 妊娠周期Eaning 断奶Earlier physical malformation 早期躯体畸形Early embryonic development 早期胚胎发育Early embryonic development to implantation 着床早期的胚胎发育Electro ejaculation 电射精Elimination 清除Embryofetal deaths 胚胎和胎仔死亡Embryo-fetal development 胚胎-胎仔发育Embryo-fetal toxicity 胚胎-胎仔毒性Embryonic death 胚胎死亡Embryonic development 胚胎发育Embryonic period 胚胎期Embryos 胚胎Embryotoxicity 胚胎毒性Enantiomer 对映异构体End of pregnancy 怀孕终止Endocytic 内吞噬(胞饮)Endocytic activity 内吞噬活性Endogenous proteins 内源性蛋白Endogenous components 内源性物质Endogenous gene 内源性基因Endonuclease 核酸内切酶Emdpmiclease release from lysosomes 溶酶体释放核酸内切酶End-point 终点Epididymal sperm maturation 附睾精子成熟性Epitope 抗原决定部位Error prone repair 易错性修复Escalation 递增Escherichia coli strain 大肠杆菌菌株Escherichia coli 大肠杆菌Evaluation of test result 试验结果评价Exaggerated pharmacological response 超常增强的药理作用Excretion 排泄(清除) Exposure assessment 接触剂量评价Exposure period 接解期External metabolizing system 体外代谢系统F1-animals 子一代动物False positive result 假阳性结果Fecundity 多产Feed-back 反馈Fertilisation 受精Fertility 生育力Fertility studies 生育力研究Fetal abnormalities 胎仔异常Fetal and neonatal parameters 胎仔和仔鼠的生长发育参数Fetal development and growth 肿仔发育和生长Fetal period 胎仔期Fetotoxicity 胎仔毒性False negative result 假阴性结果First pass testing 一期试验Fluorescence in situ hybridization(FISH) 原位荧光分子杂交----。
医药行业专业英语词汇词典
FDA和EDQM术语:CLINICAL TRIAL：临床试验ANIMAL TRIAL：动物试验ACCELERATED APPROVAL：加速批准STANDARD DRUG：标准药物INVESTIGATOR：研究人员；调研人员PREPARING AND SUBMITTING：起草和申报SUBMISSION：申报；递交BENIFITS：受益RISKS：受害DRUG PRODUCT：药物产品DRUG SUBSTANCE：原料药ESTABLISHED NAME：确定的名称GENERIC NAME：非专利名称PROPRIETARY NAME：专有名称；INNINTERNATIONAL NONPROPRIETARY NAME：国际非专有名称ADVERSE EFFECT：副作用ADVERSE REACTION：不良反应PROTOCOL：方案ARCHIVAL COPY：存档用副本REVIEW COPY：审查用副本OFFICIAL COMPENDIUM：法定药典主要指USP、 NF．USPTHE UNITED STATES PHARMACOPEIA：美国药典NFNATIONAL FORMULARY：美国国家处方集OFFICIAL＝PHARMACOPEIAL= COMPENDIAL：药典的；法定的；官方的AGENCY：审理部门指FDAIDENTITY：真伪；鉴别；特性STRENGTH：规格；规格含量每一剂量单位所含有效成分的量LABELED AMOUNT：标示量REGULATORY SPECIFICATION：质量管理规格标准NDA提供REGULATORY METHODOLOGY：质量管理方法REGULATORY METHODS VALIDATION：管理用分析方法的验证COS/CEP 欧洲药典符合性认证ICHInternational Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use人用药物注册技术要求国际协调会议ICH文件分为质量、安全性、有效性和综合学科4类..质量技术要求文件以Q开头;再以a;b;c;d代表小项:Q1:药品的稳定性Q2:方法学Q3:杂质Q4:药典Q5:生物技术产品质量Q6:标准规格Q7:GMPQ7a:原料药的优良制造规范指南药物活性成分的GMP.GMP英语PIC/S的全称为：Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme; PIC/S制药检查草案; 药品检查协会PIC/S ;也有人称PIC/S为医药审查会议/合作计划PIC/SPIC的权威翻译：药品生产检查相互承认公约APIActive Pharmaceutical Ingredient 原料药又称：活性药物组分AirLock 气闸 Authorized Person 授权人 Batch/Lot 批次Batch Number/Lot-Number 批号；Batch Numbering System 批次编码系统；Batch Records 批记录；Bulk Product 待包装品；Calibration 校正；Clean area 洁净区；ConsignmentDelivery托销药品..FDAFOOD AND DRUG ADMINISTRATION：美国食品药品管理局INDINVESTIGATIONAL NEW DRUG：临床研究申请指申报阶段;相对于NDA而言；研究中的新药指新药开发阶段;相对于新药而言;即临床前研究结束NDANEW DRUG APPLICATION：新药申请ANDAABBREVIATED NEW DRUG APPLICATION：简化新药申请TREATMENT IND：研究中的新药用于治疗ABBREVIATEDNEWDRUG：简化申请的新药DMFDRUG MASTER FILE：药物主文件持有者为谨慎起见而准备的保密资料;可以包括一个或多个人用药物在制备、加工、包装和贮存过程中所涉及的设备、生产过程或物品..只有在DMF持有者或授权代表以授权书的形式授权给FDA;FDA在审查IND、NDA、ANDA时才能参考其内容HOLDER：DMF持有者CFRCODE OF FEDERAL REGULATION：美国联邦法规PANEL：专家小组BATCH PRODUCTION：批量生产；分批生产BATCH PRODUCTION RECORDS：生产批号记录POST-OR PRE- MARKET SURVEILLANCE：销售前或销售后监督INFORMED CONSENT：知情同意患者对治疗或受试者对医疗试验了解后表示同意接受治疗或试验PRESCRIPTION DRUG：处方药OTC DRUGOVER—THE—COUNTER DRUG：非处方药GMP文件常见缩写ABPI Association of the British Pharmaceutical Industry 英国制药工业协会ADR Adverse Drug Reaction 药品不良反应AE Adverse Event 不良事件;不良反应AIM Active Ingredient Manufacturer 原料药制造商ANDA Abbreviated New Drug Application 简化新药申请ANOVA Analysis of Variance 方差分析ASM: Active Substance Manufacturer原料药制造商ATC Anatomical Therapeutic ChemicalATX Animal Test Exemption CertificateBAN British Approved NameBIRA British Institute of Regulatory AffairsBNF British National FormularyBP British PharmacopoeiaC of A Certificate of AnalysisC of S Certificate of SuitabilityCENTRE FOR DRUG EVALUATION CDECentre for Pharmaceutical Administration CPA CMS Concerned Member StateCMS每个成员国COS Certificate of SuitabilityCPMP Committee for Proprietary Medicinal Products CRA Clinical Research AssociateCRF Case Report FormCRO Contract Research OrganisationCTA Clinical Trial ApplicationCTC Clinical Trial CertificateCTD Common Technical DocumentCTX Clinical Trials ExemptionDDD Defined Daily DoseDGC Daily Global ComparisonDIA Drug Information AssociationDMF Drug Master FileDrug Registration Branch DR; Product Evaluation & Registration Division; CPAEDQM European Directorate for the Quality of Medicines 欧洲联盟药品质量指导委员会EEA 欧洲经济地区EGMA European Generics Medicine AssociationELA Established Licence ApplicationEMEA European Medicines Evaluation AgencyEMEA European Agency for the Evaluation of Medicinal Products 欧洲联盟药品评价机构EP European PharmacopoeiaEPAR European Public Assessment ReportsESRA European Society of Regulatory AffairsEuropean Pharmacopoeia Commission 欧洲药典委员会FDAFDA Food and Drug Administrationfinal evaluation report FERfree sale certificates FSCsGCP Good Clinical PracticeGCP药品临床研究管理规范GLP Good Laboratory PracticeGLP 药品临床前安全性研究质量管理规范GMP Good Manufacturing PracticeGMP 药品生产质量管理规范GSP药品销售管理规范Health Sciences Authority HSAHSA’s Medicines Advisory Committee MACIB Investigators BrochureICH International Conference for Harmonisation IDMC Independent Data-Monitoring CommitteeIEC Independent Ethics CommitteeIND Investigational New DrugINN International Non-proprietary Name International Conference on Harmonisation ICH IPC In Process ControlIRB Institutional Review BoardLICENCE HOLDERMA Marketing AuthorisationMAA Marketing Authorisation ApplicationMAA上市申请MAH Marketing Authorisation HolderMAH 销售许可持有者MCA Medicines Control AgencyMHW Ministry of Health and Welfare JapanMR Mutual RecognitionMRA 美国与欧盟的互认协议MRAs Mutual Recognition Agreements 互相认证同意MRFG Mutual Recognition Facilitation Group MRP Mutual Recognition ProcedureNAS New Active SubstanceNCE New Chemical EntityNDA New Drug Applicationnew chemical entities NCEsnew drug applications NDAsNSAID Non Steroidal Anti Inflammatory Drug NTA Notice To ApplicantsOOS Out of SpecificationOTC Over The CounterPAGB Proprietary Association of Great Britain Ph Eur European PharmacopoeiaPIL Patient Information LeafletPL Product LicencePOM Prescription Only MedicinePRODUCT OWNERPSU Periodic Safety UpdatesQA Quality AssuranceQC Quality ControlRAJ Regulatory Affairs JournalRMS Reference Member StateRMS相互认可另一成员国RSD Relative Standard DeviationRx Prescription OnlySAE Serious Adverse EventSMF Site Master FileSOP Standard Operating ProcedureSOP STANDARD OPERATION PROCEDURE 标准运作程序SPC/SmPC Summary of Product Characteristicssummary of product characteristicsSPCTherapeutic Goods Administration TGAUSP US PharmacopoeiaVMF Veterinary Master FileVPC Veterinary Products CommitteeA．A．A Addition and Amendments 增补和修订AC Air Conditioner 空调器ADR Adverse Drug Reaction 药物不良反应AFDO Association of Food and Drug Officials 食品与药品官员协会美国ACC Accept 接受AQL Acceptable Quality Level 合格质量标准ADNA Abbreviated New Drug Application 简化的新药申请BOM Bill of Material 物料清单BPC Bulk pharmaceutical Chemiclls 原料药CBER Center for Biologics Evaluation Research 生物制品评价与研究中心CFU Colony Forming Unet 菌落形成单位DMF Drug Master File 药品管理档案CDER Cemter for Drug Evaluation amd Research 药物评价与研究中心CI Corporate Identity Image 企业识别形象CIP Cleaning in Place 在线清洗CSI Consumer Safety Insepctor 消费者安全调查员CLP Cleaning Line Procedure 在线清洗程序DAL Defect Action Level 缺陷作用水平DEA Drug Enforcement Adminestration 管制药品管理DS Documentation Systim 文件系统FDA Food and Drug Administration 食品与药品管理局美国GATT General Agreemernt on Tariffs and Trade 关贸总协会GMP Good Manufacturing Practice Gvp 药品生质量管理规范GCP Good Clinical Practice 药品临床实验管理规范GLP Good Laboratory Practice 实验室管理规范GSP Good Supply Practice 药品商业质量规范GRP Gook RaTAIL Practice 药品零业质量管理规范GAP Good Agriculture Practice 药材生产管理规范GVP Gook Validation Prctice 验证管理规范GUP Gook Use Practice 药品重用规范HVAC Heating Ventilation Air Conditioning 空调净化系统ISO Intematonal Organization for Standardization 车际标准化组织MOU Memorandum of Understanding 谅解备忘录PF Porduction File 生产记录用表格OTC Over the Counter Drug 非处方药品PLA Product License Application 产品许可申请QA Quality Assurance 质量保证QC Quality Control 质量控制QMP Quality Management Procedure 质量管理程序SDA State Drug Administration 国家药品监督管理局SMP Standard Managmert Procedure 标准管理程序SOP Standard Operating Procedure 标准操作程序TQC Tatal Quality Control 全面质量管理USA Uneted States Pharmacopeia 美国药典专业英语词汇词素词根1. haplo;mono;uni ：单;一;独haploid 单倍体monoxide一氧化碳monoatomic单原子的2. bi;di;dipl;twi;du :：二;双;两;偶 biocolor 双色;dichromatic 双色的;diplobacillus 双杆菌 dikaryon 双核体twin ：孪生 dual 双重的3. tri :三;丙 triangle三角 triacylglycerol三酰甘油 tricarboxylic acid cycle 三羧酸循环4. quadri;quadru;quart;tetr;tetra：四 quadrilateral四边的 quadrivalent 四价的 quadruped四足动物tetrode四极管 tetracycline四环素5. pent;penta;quique五pentose戊糖pentagon五角形pentane戊烷quintuple 五倍的 pentose戊糖 pentomer五邻粒6. hex;hexa;sex 六 hexose已糖 hexapod六足动物hexapoda昆虫纲 hexamer 六聚体7. hepta;sept 七 heptane 庚烷 heptose 庚糖 heptoglobin七珠蛋白8. oct八 octpus 章鱼 octagon八角形 octane 辛烷 octase 辛糖9. enne;nona九 nonapeptide 九肽 enneahedron 九面体10. deca;deka 十 :decapod 十足目动物 decahedron 十面体 decagram 十克11. hecto; 百 hectometer百米 hectoliter百升 hectowatt 百瓦12. kilo;千 kilodalton KD 千道尔顿 kilobase 千碱基 kiloelectron volt 千电子伏特13. deci;十分之一;分 decimeter 分米decigram 十分之一克14. centi;百分之一15. milli;千分之一;毫millimole 毫摩尔milliliter 毫升16. micro;百万分之一;微;微小;微量microgram微克 microogranism微生物microecology微生态学micropipet微量移液器17. nano十亿分之一;毫微;纳nanosecond十亿分之一秒nanometer纳米18. demi;hemi;semi半 demibariel 半桶 hemicerebrum 大脑半球semiopaque 半透明 semi-allel半等位基因 semi-conductor半导体19. holo 全;整体;完全 holoenzyme 全酶holoprotein全蛋白 holocrine全质分泌20. mega巨大;兆;百万 megaspore大孢子;megabasse兆碱基megakaryocyte巨核细胞megavolt兆伏 megalopolitan特大城市21. macro 大;巨大;多macrophage巨噬细胞macrogamete大配子macroelement 常量元素 macromolecular大分子22. poly;multi;mult 多;复合polyacrylate聚丙烯酸酯 polymerase 聚合酶multichain多链的multinucleate 多核的 multicistronic mRNA多顺反子mRNA multicopy多拷贝1 chrom颜色chromophore生色团 chromosome染色体 chromatography色谱法2 melan;melano;nigr 黑melanoma黑素瘤melanin黑色素melanophore黑色素细胞3 xantho;flavo;fla;flavi;lute黄xanthophyl叶黄素 xanthous黄色的;黄色人种xathine黄嘌呤 flavin黄素flavone黄酮 letein黄体素;叶黄素flavin adenine dinucleotideFAD黄素腺嘌呤二核苷酸4 erythro; rub; rubrm; ruf;红erythrocyte红细胞erythromycin红霉素erythropoitinEPO促红细胞生成素5 chloro;chlor绿;氯chlorophyll叶绿素 chloride氯化物chloramphenicol氯霉素6 cyan;cyano 蓝;青紫色;氰cyanophyceae 蓝藻纲 cyanobacteria蓝细菌cyanide氰化物7 aur;glid;chrys金色aureomycin金霉素chrysose 金藻淀粉 chrysanthemum菊花 glidstone 金沙石glid 镀金8 leu;leuco;leuk;leuko;blan;alb无色;白色leucine亮氨酸leukaemia=leucosis白血病bleaching powder漂白粉albomycin白霉素四表示方位和程度的词素1 endo;ento;内;在内endocrine内分泌endocytosis胞吞作用 endogamy近亲繁殖 endolysin内溶素entoderm内胚层2 ec; ect; exc; extra 外;外面;表面ectoblast外胚层 ectoparasite 外寄生生物 extract 抽取;浸出3 meso 中;中间mesosphere 中圈;中层 mesoplast 中胚层质4 intra;intro;inter 在内;向内intra-allelic interaction 等位基因内相互作用 intracellular细胞内的interurban城市之间5 centri;centro;medi;mid 中心;中央;中间centrifuge离心 centriole 中心粒centrosome 中心体 centrogeng着丝基因6 epi;peri 上;外;旁epidermal growth factorEGF: 表皮生长因子 epibranchial上鳃的perilune 近月点7 sub;suc;suf;sug 下;低;小suborder 亚目 submucosa粘膜下层subclone亚克隆 subcellular亚细胞subsection小节;分部8 super;supra 上;高;超superconductor超导体superfluid 超流体superoxide 超氧化物supramolecular超分子的9 hyper 超过;过多hypersensitive 过敏的hyperelastic 超弹性的hypertension 高血压hyperploid 超倍体10 hypo下;低;次hypoglycaemia 低血糖 hypotension低血压hypophysis脑下垂体11 iso 等;相同;同iso-osmotic等渗的isopod等足目动物 isotope同位素12 oligo;olig少;低;寡;狭oligohaline 狭盐性 oligogene寡基因 oligomer寡聚体 oligophagous寡食性oligarchy寡头13 eury 多;宽;广eurythermal 广温的 euryhaline广盐性eurytopic species广幅种14 ultr 超ultra-acoustics 超声学ultra-structure超微结构ultroviolet紫外线15 infra 下;低;远infralittoral 潮下带;远岸的infrahuman类人生物infrared红外线的infrastructure基础结构;基本结构五表示动物不同器官和组织的词素1 cephal;capit;cran 头;头颅2 cyte 细胞3 carn;my;mya;myo;肉;肌肉4 haem;haemat;hem;aem;sangul 血5 soma;corp 体;身体6 some;plast 体;颗粒7 hepa;hepat 肝 heparin 肝素 hepatopancreas肝胰腺 hepatocyte 肝细胞hepatoma肝癌8 ren;nephr 肾adrnal肾上腺的 nephridia肾管 nephron肾单位9 card;cord 心 cardiotoxin 心脏毒素 cardiovascular center 心血管中枢electrocardiogram心电图 concord一致;和谐10 ophthalm;ocell;ocul 眼ophthalmology眼科学ophthalmia眼炎ophthalmologist眼科专家11 branchi 鳃 filibranch丝鳃 lamellibrnch瓣鳃 sencondary branchium次生鳃12 brac ;brachi 腕;手臂 brachiolaria 短腕幼虫brachionectin臂粘连蛋白bracelet手镯13 dent;odont 牙齿 dentin牙质 odontphora 齿舌 odontoblast成牙质细胞14 plum羽 plumatus 羽状的 plumule绒毛 plumage 鸟的羽毛15 foli;foil 叶 follicle滤泡 foiling叶形 foliage 叶子 foliose 多叶的药名常用词首ace- 乙酰基acet- 醋；醋酸；乙酸acetamido- 乙酰胺基acetenyl- 乙炔基acetoxy- 醋酸基；乙酰氧基acetyl- 乙酰基aetio- 初allo- 别allyl- 烯丙基；CH2=CH-CH2-amido- 酰胺基amino- 氨基amyl- ①淀粉②戊基amylo- 淀粉andr- 雄andro- 雄anilino- 苯胺基anisoyl- 茴香酰；甲氧苯酰anti- 抗apo- 阿朴；去水aryl- 芳香基aspartyl- 门冬氨酰auri- 金基；三价金基aza- 氮杂azido- 叠氮azo- 偶氮basi- 碱baso- 碱benxoyl- 苯酰；苯甲酰benzyl- 苄基；苯甲酰bi- 二；双；重biphenyl- 联苯基biphenylyl- 联苯基bis- 双；二bor- 硼boro- 硼bromo- 溴butenyl- 丁烯基有1、2、3位三种butoxyl- 丁氧基butyl- 丁基butyryl- 丁酰caprinoyl- 癸酰caproyl- 己酰calc- 钙calci- 钙calco- 钙capryl- 癸酰capryloyl- 辛酰caprylyl- 辛酰cef- 头孢头孢菌素族抗生素词首chlor- ①氯②绿chloro- ①氯②绿ciclo- 环cis- 顺clo- 氯crypto- 隐cycl- 环cyclo- 环de- 去；脱dec- 十；癸deca- 十；癸dehydro- 去氢；去水demethoxy- 去甲氧基demethyl- 去甲基deoxy- 去氧des- 去；脱desmethyl- 去甲基desoxy- 去氧dex- 右旋dextro- 右旋di- 二diamino- 二氨基diazo- 重氮dihydro- 二氢；双氢endo- 桥epi- 表；差向epoxy- 环氧erythro- 红；赤estr- 雌ethinyl- 乙炔基ethoxyl- 乙氧基ethyl- 乙基etio- 初eu- 优fluor- ①氟②荧光fluoro- ①氟②荧光formyl- 甲酰基guanyl- 脒基hepta- 七；庚hetero- 杂hexa- 六；己homo- 高比原化合物多一个-CH2-hypo- 次io- 碘indo- 碘iso- 异keto- 酮laevo- 左旋leuco- 白levo- 左旋mercapto- 巯基meso- ①不旋；内消旋②中间③中位蒽环的9、10位meta- ①间有机系统用名②偏无机酸用methoxy- 甲氧基methyl- 甲基mono- 一；单neo- 新nitro- 硝基nitroso- 亚硝基nona- 九；壬nor- 去甲；降；正nov- 新novo- 新oct- 八；辛octa- 八；辛octo- 八；辛ortho- ①邻位②正③原oxalo- 草oxo- 氧代oxy- ①氧②羟基误称;但常用para- ①对位②副俗名penta- 五；戊per- ①高②过phen- 苯pheno- 苯phenoxy- 苯氧基phenyl- 苯基phospho- 磷；磷酸phosphor- 磷；磷酸phosphoro- 磷；磷酸phyllo- 叶poly- 多；聚propyl- 丙基proto- 原pseudo- 假；伪；拟ribosyl- 核糖基sec- ①另指CH3CH2CHCH3-型烃基②semi- 半silico- 硅strept- 链strepto- 链sulf- 硫sulfa- 磺胺磺胺类药物词头sulfo- ①硫代②磺基sulph- 硫代sulpho- ①硫代②磺基tert- ①特指CH3…CCH32-型烃基②叔tetra- 四thio- 硫trans- 反式；转tri- 三undeca- 十一valyl- 缬氨酰基vinyl- 乙烯基xantho- 黄色药名常用词尾-al 醛-aldehyde 醛-amide 酰胺-amidine 脒-amine 胺-ane 烷-ase 酶-ate ①盐②酯-azide 叠氮；-N3-caine 卡因局部麻醉药词尾-carbonyl 羰基-carboxamide 甲酰胺-carboxylic acid 羧酸-cidin 杀……菌素-cillin 青霉素；西林青霉素族抗生素词尾-cycline 四环素四环素族抗生素词尾-diol ①二醇②二酚-dione 二酮-disulfide 二硫化物-ene 烯-enol 烯醇-ester 酯-flavine 黄素-form 仿俗名词尾-genin 甙元旧称配基-hydrin 醇-ine 碱；素生物碱词尾-lactone 内酯-lysin 溶素俗名词尾-micin 霉素抗生素词尾-mycetin 霉素；菌素抗生素词尾-mycin 霉素抗生素词尾-nitrile 腈-ol ①醇②酚-olol 心安心安类药物词尾-one 酮-ose 糖-oside 糖甙-oxide 氧；氧化物-oyl 酰-quine 奎俗名尾词-sporin 孢菌素抗生素词尾-sullide 硫化物-sulfone 砜-sulfoxide 亚砜-thioic acid 硫代酸-thione 硫酮-thione 硫酮-toxin 毒-triol 三醇-tropin 托品俗名尾词-urea 脲-xanthin 黄质-yl 基一价基-yne 炔常用分析化学词汇C to E玻璃漏斗 Glass funnel long stem试管 test tube test tube brush test tube holder test tube rack 蒸发皿 evaporating dish small烧杯 beaker锥形瓶 Erlenmeyer量筒 grad cylinder洗瓶 plastic wash bottle勺皿 casserole ;smallstoppered flask分液漏斗 separalory funnelwater bath/oil bathstrring barmagnetic stirrer冷凝器 condenserBallast bottle圆颈烧瓶 Round-buttom flask试剂瓶 reagent bottles托盘天平 platform balance 台秤0.1g 托盘pan 指针刻度表pointer and scale crossbeams and sliding weights 游码分析天平 two-pan/single-pan analytical balance 滴定管 burette glass beadbasic nozzle移液管 pipette 胖肚 elongated glass bulb洗耳球 rubber suction bulb玻棒 glass rod玻璃活塞 stopcock容量瓶 pyknowmeter flasks比重瓶 one-markvolumetric flasks胖肚吸管 one-mark pipette刻度吸管 graduated pipettes实验仪器清单1、柜子中四、抽屉中：锥形瓶conical flask 250ml×4 药匙medicine spoon×1Erlenmeyer flask 100 ml×3 滴管drip tube;dropper×2烧杯beaker 500 ml×1 玻棒Glass stic×2250 ml×3 木试管夹test tube clamp;test tube holder×1100 ml×3 胖肚吸管straws 25 ml×150 ml×2 10 ml×1容量瓶volumetric flask 100 ml×2 乳钵morta×150 ml×4 洗耳球ear wadhing bulb碘量瓶 iodin numoe flask;iodineflask 500 ml×3试剂瓶 reagent bottle 无色×2棕色×2 配洗液：量筒cylinder 100 ml×1 K2Cr2O72g+5ml水→65mlH2SO4graduated cylinder10ml×1 边加边搅拌stir..二、台面上仪器：一般仪器的洗涤wash铁支架siderocradle+蝴蝶架白瓷板White Porcelain Board 一清点仪器to count;to make an inventory酸式滴定管Acid burette 25 ml×1 配洗液 Lotion碱式滴定管Alkali burette25 ml×1 一般仪器的洗涤三、公用柜中：二滴定管buret;burette直型冷凝器rectocondensor×1 容量瓶volumetric flask漏斗架 funnel stand ×2 移液管pipe水浴锅water bath kettle ×1温度计Thermometer;hygrometer;hydroscope ×1电炉electric furnace;electric hot plate;electric stove 四人一个分析化学：analytical chemistry定性分析：qualitative analysis定量分析：quantitative analysis物理分析：physical analysis物理化学分析：physico-chemical analysis仪器分析法：instrumental analysis流动注射分析法：flow injection analysis；FIA顺序注射分析法：sequentical injection analysis;SIA化学计量学：chemometrics绝对误差：absolute error相对误差：relative error系统误差：systematic error可定误差：determinate error随机误差：accidental error不可定误差：indeterminate error准确度：accuracy精确度：precision偏差：debiation;d平均偏差：average debiation相对平均偏差：relative average debiation标准偏差标准差：standerd deviation;S相对平均偏差：relatibe standard deviation;RSD变异系数：coefficient of variation误差传递：propagation of error有效数字：significant figure置信水平：confidence level显着性水平：level of significance合并标准偏差组合标准差：pooled standard debiation 舍弃商：rejection quotient ;Q滴定分析法：titrametric analysis滴定：titration容量分析法:volumetric analysis化学计量点：stoichiometric point等当点：equivalent point电荷平衡：charge balance电荷平衡式：charge balance equation质量平衡：mass balance物料平衡：material balance质量平衡式：mass balance equation酸碱滴定法：acid-base titrations质子自递反应：autoprotolysis reaction质子自递常数：autoprotolysis constant质子条件式:proton balance equation酸碱指示剂：acid-base indicator指示剂常数：indicator constant变色范围：colour change interval混合指示剂：mixed indicator双指示剂滴定法：double indicator titration 非水滴定法：nonaqueous titrations质子溶剂：protonic solvent酸性溶剂：acid solvent碱性溶剂：basic solvent两性溶剂:amphototeric solvent无质子溶剂：aprotic solvent均化效应：differentiating effect区分性溶剂：differentiating solvent离子化：ionization离解：dissociation结晶紫：crystal violet萘酚苯甲醇: α-naphthalphenol benzyl alcohol奎哪啶红：quinadinered百里酚蓝：thymol blue偶氮紫：azo violet溴酚蓝：bromophenol blue配位滴定法：compleximetry乙二胺四乙酸：ethylenediamine tetraacetic acid;EDTA 螯合物：chelate compound金属指示剂：metal lochrome indcator氧化还原滴定法：oxidation-reduction titration碘量法：iodimetry溴量法：bromimetry溴量法：bromine method铈量法：cerimetry高锰酸钾法：potassium permanganate method条件电位：conditional potential溴酸钾法：potassium bromate method硫酸铈法：cerium sulphate method偏高碘酸：metaperiodic acid高碘酸盐：periodate亚硝酸钠法：sodium nitrite method重氮化反应：diazotization reaction重氮化滴定法：diazotization titration亚硝基化反应：nitrozation reaction亚硝基化滴定法：nitrozation titration外指示剂：external indicator外指示剂：outside indicator重铬酸钾法：potassium dichromate method沉淀滴定法：precipitation titration容量滴定法：volumetric precipitation method 银量法：argentometric method重量分析法：gravimetric analysis挥发法：volatilization method引湿水湿存水：water of hydroscopicity包埋藏水：occluded water吸入水：water of imbibition结晶水：water of crystallization组成水：water of composition液-液萃取法：liquid-liquid extration溶剂萃取法：solvent extration反萃取：counter extraction分配系数：partition coefficient分配比：distribution ratio离子对离子缔合物：ion pair沉淀形式：precipitation forms称量形式：weighing forms物理分析：physical analysis物理化学分析：physicochemical analysis 仪器分析：instrumental analysis电化学分析：electrochemical analysis 电解法：electrolytic analysis method 电重量法：electtogravimetry库仑法：coulometry库仑滴定法：coulometric titration电导法：conductometry电导分析法：conductometric analysis电导滴定法：conductometric titration 电位法：potentiometry直接电位法：dirext potentiometry电位滴定法：potentiometric titration 伏安法：voltammetry极谱法：polarography溶出法：stripping method电流滴定法：amperometric titration化学双电层：chemical double layer相界电位：phase boundary potential金属电极电位：electrode potential化学电池：chemical cell液接界面：liquid junction boundary原电池：galvanic cell电解池：electrolytic cell负极：cathrode正极：anode电池电动势：eletromotive force指示电极：indicator electrode参比电极：reference electroade标准氢电极：standard hydrogen electrode一级参比电极：primary reference electrode饱和甘汞电极：standard calomel electrode银－氯化银电极：silver silver-chloride electrode 液接界面：liquid junction boundary不对称电位：asymmetry potential表观PH值：apparent PH复合PH电极：combination PH electrode离子选择电极：ion selective electrode敏感器：sensor晶体电极:crystalline electrodes均相膜电极：homogeneous membrance electrodes非均相膜电极：heterog eneous membrance electrodes非晶体电极：non- crystalline electrodes刚性基质电极：rigid matrix electrode流流体载动电极：electrode with a mobile carrier气敏电极：gas sensing electrodes酶电极：enzyme electrodes金属氧化物半导体场效应晶体管：MOSFET离子选择场效应管：ISFET总离子强度调节缓冲剂：total ion strength adjustment buffer;TISAB永停滴定法：dead-stop titration双电流滴定法双安培滴定法：double amperometric titration普朗克常数：Plank constant电磁波谱：electromagnetic spectrum光谱：spectrum光谱分析法：spectroscopic analysis原子发射光谱法：atomic emission spectroscopy质量谱：mass spectrum质谱法：mass spectroscopy;MS紫外－可见分光光度法：ultraviolet and visible spectrophotometry;UV-vis 肩峰：shoulder peak末端吸收：end absorbtion生色团：chromophore助色团：auxochrome红移：red shift长移：bathochromic shift短移：hypsochromic shift蓝紫移：blue shift增色效应浓色效应：hyperchromic effect减色效应淡色效应：hypochromic effect强带：strong band弱带：weak band吸收带：absorption band透光率：transmitance;T吸光度：absorbance谱带宽度：band width杂散光：stray light噪声：noise暗噪声：dark noise散粒噪声：signal shot noise闪耀光栅：blazed grating全息光栅：holographic graaing光二极管阵列检测器：photodiode array detector 偏最小二乘法：partial least squares method ;PLS褶合光谱法：convolution spectrometry褶合变换：convolution transform;CT离散小波变换：wavelet transform;WT多尺度细化分析：multiscale analysis供电子取代基：electron donating group吸电子取代基：electron with-drawing group 荧光：fluorescence荧光分析法：fluorometryX-射线荧光分析法：X-ray fulorometry原子荧光分析法：atomic fluorometry分子荧光分析法：molecular fluorometry振动弛豫：vibrational relexation内转换：internal conversion外转换：external conversion体系间跨越：intersystem crossing激发光谱：excitation spectrum荧光光谱：fluorescence spectrum斯托克斯位移：Stokes shift荧光寿命：fluorescence life time荧光效率：fluorescence efficiency荧光量子产率：fluorescence quantum yield 荧光熄灭法：fluorescence quemching method散射光：scattering light瑞利光：Reyleith scanttering light拉曼光：Raman scattering light红外线：infrared ray;IR中红外吸收光谱：mid-infrared absorption spectrum;Mid-IR 远红外光谱：Far-IR微波谱：microwave spectrum;MV红外吸收光谱法：infrared spectroscopy红外分光光度法：infrared spectrophotometry振动形式：mode of vibration伸缩振动：stretching vibration对称伸缩振动：symmetrical stretching vibration不对称伸缩振动：asymmetrical stretching vibration弯曲振动：bending vibration变形振动：formation vibration面内弯曲振动:in-plane bending vibration;β剪式振动：scissoring vibration;δ面内摇摆振动：rocking vibration;ρ核磁共振：nuclear magnetic resonance;NMR核磁共振波谱：NMR spectrum核磁共振波谱法：NMR spectroscopy扫场：swept field扫频：seept frequency连续波核磁共振：continuous wave NMR;CW NMRFourier变换NMR：PFT-NMR;FT-NMR二维核磁共振谱：2D-NMR质子核磁共振谱：proton magnetic resonance spectrum;PMR 氢谱：1H-NMR碳－13核磁共振谱：13C-NMR spectrum;13CNMR自旋角动量：spin angular momentum磁旋比：magnetogyric ratio磁量子数：magnetic quantum number;m进动：precession弛豫历程：relaxation mechanism局部抗磁屏蔽：local diamagnetic shielding屏蔽常数：shielding constant化学位移：chemical shift国际纯粹与应用化学协会：IUPAC磁各向异性：magnetic anisotropy远程屏蔽效应：long range shielding effect结面：nodal plane自旋－自旋偶合：spin-spin coupling自旋－自旋分裂：spin=spin splitting单峰：singlet;s双峰：doublet;d三重峰：triplet;t四重峰：quartet五重峰：quintet六重峰：sextet偕偶：geminal coupling邻偶：vicinal coupling远程偶合：long range coupling磁等价：magnetic eqivalence自旋系统：spin system一级光谱：first order spectrum二级光谱二级图谱：second order spectrumC-H光谱：C-H correlated spectroscopy;C-H COSY质谱分析法：mass spectrometry质谱：mass spectrum;MS棒图：bar graph选择离子检测：selected ion monitoring ;SIM直接进样：direct probe inlet ;DPI接口：interface气相色谱－质谱联用：gas chromatography-mass spectrometry;GC-MS高效液相色谱－质谱联用：high performance liquid chromatography-mass spectrometry;HPLC-MS电子轰击离子源：electron impact source;EI离子峰：quasi-molecular ions化学离子源：chemical ionization source;CI场电离：field ionization;FI场解析：field desorptiion;FD快速原子轰击离子源：fast stom bombardment ;FAB质量分析器：mass analyzer磁质谱仪：magnetic-sector mass spectrometer四极杆质谱仪四极质谱仪：quadrupole mass spectrometer 原子质量单位:amu离子丰度：ion abundance相对丰度相对强度：relative avundance基峰：base peak质量范围：mass range分辨率：resolution灵敏度：sensitivity信噪比：S/N分子离子：molecular ion碎片离子：fragment ion同位素离子：isotopic ion亚稳离子：metastable ion亚稳峰：metastable peak母离子：paren ion子离子：daughter含奇数个电子的离子：odd electron含偶数个电子的离子：even eletron;EE均裂：homolytic cleavage异裂非均裂：heterolytic cleavage半均裂：hemi-homolysis cleavage重排：rearragement分子量：MWα－裂解：α-cleavage固定相：stationary phase化学键合相：chemically bonde phase封尾、封顶、遮盖：end capping手性固定相：chiral stationary phase;CSP恒组成溶剂洗脱：isocraic elution梯度洗脱：gradient elution紫外检测器：ultraviolet detector;UVD荧光检测器：fluorophotomeric detector;FD电化学检测器：ECD示差折光检测器：RID光电二极管检测器：photodiode array detector ;DAD 三维光谱－波谱图：3D-spectrochromatogram蒸发光散射检测器：evaporative light scattering detector;ELSD 释药系统drug delivery system;DDS中国药典Chinese Pharmacopoeia;ChP美国药典The United States Pharmacopoeia;USP美国国家处方集The National Formulary;NF英国药典British Pharmacopoeia;BP欧洲药典European Pharmacopoeia;Ph.Eup国际药典The International Pharmacopoeia;Ph.Int良好药品实验研究规范Good Laboratory Practice;GLP良好药品生产规范Good Manufacture Practice;GMP良好药品供应规范Good Supply Practice;GSP良好药品临床试验规范Good Clinical Practice;GCP分析质量管理Analytical Quality Control;AQC边缘效应 edge effect斑点定位法 localization of spot放射自显影法 autoradiography原位定量 in situ quantitation生物自显影法 bioautography归一法 normalization method内标法 internal standard method外标法 external standard method叠加法 addition method普适校准曲线、函数 calibration function or curve function谱带扩展加宽 band broadening分离作用的校准函数或校准曲线 universal calibration function or curve of separation加宽校正 broadening correction加宽校正因子 broadening correction factor溶剂强度参数ε0;solvent strength parameter洗脱序列 eluotropic series洗脱淋洗 elution等度洗脱 gradient elution梯度洗脱 gradient elution再循环洗脱 recycling elution线性溶剂强度洗脱 linear solvent strength gradient程序溶剂 programmed solvent程序压力 programmed pressure程序流速 programmed flow展开 development上行展开 ascending development下行展开 descending development双向展开 two dimensional development环形展开 circular development离心展开 centrifugal development向心展开 centripetal development径向展开 radial development多次展开 multiple development分步展开 stepwise development连续展开 continuous development梯度展开 gradient development匀浆填充 slurry packing停流进样 stop-flow injection阀进样 valve injection柱上富集 on-column enrichment流出液 eluate柱上检测 on-column detection柱寿命 column life柱流失 column bleeding显谱 visualization活化 activation反冲 back flushing脱气 degassing沟流 channeling过载 overloading分析化学方面的词汇abatement 1:减少 2：消除；ablution 1:清洗 2：洗净液；。
FDA专业词汇整理
melting points 熔点 lab scale 实验室规模 API 主药 XRPD X 光粉末衍射技术 Utilize 利用 phase transition 相变 morphology 形态 Approximately 大约的 Biopharmaceutics Classification System (BCS). 生物药剂学分类 系统 Hygroscopicity 引湿性 Density 密度 Bulk Density 松密度 Tapped Density 堆密度 Flow property 流动性 Amorphous 无定形的 Stress testing 影响因素实验 degradation pathway 降解途径 accelerated testing 加速实验 oxidation 氧化 photolysis 光解 reasonable 合理的 Degradation peaks 降解峰 peak purity 峰纯度 Thermostability 热稳定性 Photolytic Stability 光稳定性 Oxidative Stability 氧稳定性 Partition coefficient 分配系数 Caco-2 permeability: Caco-2 细胞
Expiry date 过期时间 Average weight 平均片重 Related Compound 有关物质 pharmaceutical development 制剂 开发 BCS Class 生物药剂学分类 aqueous solubility 水溶性 physiological pH range 生理 pH 范围 buffer solution 缓冲溶液 mean absolute bioavailability 平 均绝对生物利用度 terminal elimination half-life 最终消除的半衰期 Properties 特性，性质 safety and efficacy 安全性及有效 性 orally disintegrating tablet 口腔崩 解片 scored 有刻痕的 Route of administration 给药途径 Bioequivalence 生物等效性 shelf-life 货架期 Microbial Limits 微生物限度 pharmacopoeia criteria 药典标准 crystals 结晶粉末 Salt form 盐型 crystallization conditions 结晶条 件 solvents 溶剂
FDA常用英文词汇翻译
FDA常用英文词汇翻译FDA（FOOD AND DRUG ADMINISTRA TION)：（美国)食品药品管理局IND（INVESTIGA TIONAL NEW DRUG)：临床研究申请（指申报阶段,相对于NDA而言)；研究中的新药（指新药开发阶段，相对于新药而言，即临床前研究结束)NDA（NEW DRUG APPLICATION)：新药申请ANDA（ABBREVIATED NEW DRUG APPLICATION)：简化新药申请EP诉（EXPORT APPLICATION)：出口药申请（申请出口不被批准在美国销售的药品) TREATMENT IND：研究中的新药用于治疗ABBREVIATED（NEW)DRUG：简化申请的新药DMF（DRUG MASTER FILE)：药物主文件（持有者为谨慎起见而准备的保密资料，可以包括一个或多个人用药物在制备、加工、包装和贮存过程中所涉及的设备、生产过程或物品。
只有在DMF持有者或授权代表以授权书的形式授权给FDA，FDA在审查IND、NDA、ANDA时才能参考其内容)HOLDER：DMF持有者CFR（CODE OF FEDERAL REGULATION)：（美国)联邦法规PANEL：专家小组BA TCH PRODUCTION：批量生产；分批生产BA TCH PRODUCTION RECORDS：生产批号记录POST-OR PRE- MARKET SURVEILLANCE：销售前或销售后监督INFORMED CONSENT：知情同意（患者对治疗或受试者对医疗试验了解后表示同意接受治疗或试验)PRE<I>script</I>ION DRUG：处方药OTC DRUG（OVER—THE—COUNTER DRUG)：非处方药U．S．PUBLIC HEALTH SERVICE：美国卫生福利部NIH（NATIONAL INSTITUTE OF HEALTH)：（美国)全国卫生研究所CLINICAL TRIAL：临床试验ANIMAL TRIAL：动物试验ACCELERATED APPROV AL：加速批准STANDARD DRUG：标准药物INVESTIGATOR：研究人员；调研人员PREPARING AND SUBMITTING：起草和申报SUBMISSION：申报；递交BENIFIT（S)：受益RISK（S)：受害DRUG PRODUCT：药物产品DRUG SUBSTANCE：原料药ESTABLISHED NAME：确定的名称GENERIC NAME：非专利名称PROPRIETARY NAME：专有名称；INN（INTERNATIONAL NONPROPRIETARY NAME)：国际非专有名称NARRA TIVE SUMMARY记叙体概要ADVERSE EFFECT：副作用ADVERSE REACTION：不良反应PROTOCOL：方案ARCHIV AL COPY：存档用副本REVIEW COPY：审查用副本OFFICIAL COMPENDIUM：法定药典（主要指USP、NF)．USP（THE UNITED STATES PHARMACOPEIA)：美国药典（现已和NF合并一起出版) NF（NATIONAL FORMULARY)：（美国)国家药品集OFFICIAL＝PHARMACOPEIAL= COMPENDIAL：药典的；法定的；官方的AGENCY：审理部门（指FDA) 医学全在线www.med126.c omSPONSOR：主办者（指负责并着手临床研究者)IDENTITY：真伪；鉴别；特性STRENGTH：规格；规格含量（每一剂量单位所含有效成分的量)LABELED AMOUNT：标示量REGULATORY SPECIFICATION：质量管理规格标准（NDA提供)REGULATORY METHODOLOGY：质量管理方法（FDA用于考核原料药或药物产品是否符合批准了的质量管理规格标准的整套步骤)REGULATORY METHODS V ALIDATION：管理用分析方法的验证（FDA对NDA提供的方法进行验证)Dietary supplement：食用补充品PRE<I>script</I>ION DRUG：处方药OTC DRUG（OVER—THE—COUNTER DRUG)：非处方药U．S．PUBLIC HEALTH SERVICE：美国卫生福利部NIH（NATIONAL INSTITUTE OF HEALTH)：（美国)全国卫生研究所CLINICAL TRIAL：临床试验ANIMAL TRIAL：动物试验ACCELERATED APPROV AL：加速批准STANDARD DRUG：标准药物INVESTIGATOR：研究人员；调研人员PREPARING AND SUBMITTING：起草和申报SUBMISSION：申报；递交BENIFIT（S)：受益医.学全,在.线,提供w w w.m e d126.c omRISK（S)：受害DRUG PRODUCT：药物产品DRUG SUBSTANCE：原料药ESTABLISHED NAME：确定的名称GENERIC NAME：非专利名称PROPRIETARY NAME：专有名称；INN（INTERNATIONAL NONPROPRIETARY NAME)：国际非专有名称NARRA TIVE SUMMARY记叙体概要ADVERSE EFFECT：副作用ADVERSE REACTION：不良反应PROTOCOL：方案ARCHIV AL COPY：存档用副本REVIEW COPY：审查用副本OFFICIAL COMPENDIUM：法定药典（主要指USP、NF)．USP（THE UNITED STATES PHARMACOPEIA)：美国药典（现已和NF合并一起出版) NF（NATIONAL FORMULARY)：（美国)国家药品集OFFICIAL＝PHARMACOPEIAL= COMPENDIAL：药典的；法定的；官方的AGENCY：审理部门（指FDA)SPONSOR：主办者（指负责并着手临床研究者)IDENTITY：真伪；鉴别；特性STRENGTH：规格；规格含量（每一剂量单位所含有效成分的量)LABELED AMOUNT：标示量REGULATORY SPECIFICATION：质量管理规格标准（NDA提供)REGULATORY METHODOLOGY：质量管理方法（FDA用于考核原料药或药物产品是否符合批准了的质量管理规格标准的整套步骤)REGULATORY METHODS V ALIDATION：管理用分析方法的验证（FDA对NDA提供的方法进行验证)Dietary supplement：食用补充品。
FDA有关术语中英对照
FDA（FOOD AND DRUG ADMINISTRATION）：（美国）食品药品管理局IND（INVESTIGATIONAL NEW DRUG）：临床研究申请（指申报阶段,相对于NDA 而言）；研究中的新药（指新药开发阶段，相对于新药而言，即临床前研究结束）NDA（NEW DRUG APPLICATION）：新药申请ANDA（ABBREVIATED NEW DRUG APPLICATION）：简化新药申请EP诉（EXPORT APPLICATION）：出口药申请（申请出口不被批准在美国销售的药品）TREATMENT IND：研究中的新药用于治疗ABBREVIATED（NEW）DRUG：简化申请的新药DMF（DRUG MASTER FILE）：药物主文件（持有者为谨慎起见而准备的保密资料，可以包括一个或多个人用药物在制备、加工、包装和贮存过程中所涉及的设备、生产过程或物品。
只有在DMF持有者或授权代表以授权书的形式授权给FDA，FDA在审查IND、NDA、ANDA时才能参考其内容）HOLDER：DMF持有者CFR（CODE OF FEDERAL REGULATION）：（美国）联邦法规PANEL：专家小组BATCH PRODUCTION：批量生产；分批生产BATCH PRODUCTION RECORDS：生产批号记录POST-OR PRE- MARKET SURVEILLANCE：销售前或销售后监督INFORMED CONSENT：知情同意（患者对治疗或受试者对医疗试验了解后表示同意接受治疗或试验）PRESCRIPTION DRUG：处方药OTC DRUG（OVER—THE—COUNTER DRUG）：非处方药FDA（FOOD AND DRUG ADMINISTRATION）：（美国）食品药品管理局IND（INVESTIGATIONAL NEW DRUG）：临床研究申请（指申报阶段,相对于NDA 而言）；研究中的新药（指新药开发阶段，相对于新药而言，即临床前研究结束）NDA（NEW DRUG APPLICATION）：新药申请ANDA（ABBREVIATED NEW DRUG APPLICATION）：简化新药申请EP诉（EXPORT APPLICATION）：出口药申请（申请出口不被批准在美国销售的药品）TREATMENT IND：研究中的新药用于治疗ABBREVIATED（NEW）DRUG：简化申请的新药DMF（DRUG MASTER FILE）：药物主文件（持有者为谨慎起见而准备的保密资料，可以包括一个或多个人用药物在制备、加工、包装和贮存过程中所涉及的设备、生产过程或物品。
FDA术语表
FDA GlossaryCompiled by: Yaw-Tsong Lee Last updated: 13 September 2009[Top] [Laws & Regulations] [FDA Organization] [SFDA][Top] [Laws & Regulations] [FDA Organization] [SFDA]FDA Organization Charts[Top] [Laws & Regulations] [FDA Organization] [SFDA][Top] [Laws & Regulations] [FDA Organization] [SFDA]1 of the Bureau of Customs and Border Protection (CBP)2 An unintended reaction to a drug taken at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function. In clinical trials, an ADR would include any injuries by overdosing, abuse/dependence, and unintended interactions with other medicinal products.3 An unwanted effect caused by the administration of drugs. Onset may be sudden or develop over time4 Organizations and groups that actively support participants and their families with valuable resources, including self-empowerment and survival tools.5 A negative experience encountered by an individual during the course of a clinical trial that is associated with the drug.6 An alanine aminotransferase (ALT) test measures the amount of this enzyme in the blood. ALT is measured to see if the liver is damaged or diseased.7 to check for liver disease or damage to the liver. Symptoms of liver disease can include jaundice, belly pain, nausea, and vomiting. An ALP test may also be used to check the liver when medicines that can damage the liver are taken or to check bone problems (sometimes found on X-rays), such as rickets, osteomalacia, bone tumors, Paget's disease, or too much of the hormone that controls bone growth (parathyroid hormone).8 Any of the treatment groups in a randomized trial.9 Low levels of AST are normally found in the blood. When body tissue or an organ such as the heart or liver is diseased or damaged, additional AST is released into the bloodstream. The amount of AST in the blood is directly related to the extent of the tissue damage.10 A renewable permit granted by the federal government to an institution or research center to conduct clinical trials.11 Benzodiazepines have also been used as a "date rape" drug because they can markedly impair and even abolish functions that normally allow a person to resist or even want to resist sexual aggression or assault12本类药物也称弱安定药，包括氯氮卓(利眠宁，chlordiazepoxide，商品名Librium)、地西泮(安定，diazepam，商品名valium)、硝西泮(硝基安定，nitrazepam)、氟西泮(氟安定，flurazepam)及奥沙西泮(去甲羟基安定，舒宁，oxazepam)。
FDA有关术语
FDA有关术语FDA（FOOD AND DRUG ADMINISTRATION）：（美国）食品药品管理局IND（INVESTIGATIONAL NEW DRUG）：临床研究申请（指申报阶段,相对于NDA而言）；研究中的新药（指新药开发阶段，相对于新药而言，即临床前研究结束）NDA（NEW DRUG APPLICATION）：新药申请ANDA（ABBREVIATED NEW DRUG APPLICATION）：简化新药申请EP诉（EXPORT APPLICATION）：出口药申请（申请出口不被批准在美国销售的药品）TREATMENT IND：研究中的新药用于治疗ABBREVIATED（NEW）DRUG：简化申请的新药DMF（DRUG MASTER FILE）：药物主文件（持有者为谨慎起见而准备的保密资料，可以包括一个或多个人用药物在制备、加工、包装和贮存过程中所涉及的设备、生产过程或物品。
只有在DMF持有者或授权代表以授权书的形式授权给FDA，FDA在审查IND、NDA、ANDA时才能参考其内容）HOLDER：DMF持有者CFR（CODE OF FEDERAL REGULATION）：（美国）联邦法规PANEL：专家小组BATCH PRODUCTION：批量生产；分批生产BATCH PRODUCTION RECORDS：生产批号记录POST-OR PRE- MARKET SURVEILLANCE：销售前或销售后监督INFORMED CONSENT：知情同意（患者对治疗或受试者对医疗试验了解后表示同意接受治疗或试验）PRESCRIPTION DRUG：处方药OTC DRUG（OVER—THE—COUNTER DRUG）：非处方药以上信息来自中国医药资讯网U．S．PUBLIC HEALTH SERVICE：美国卫生福利部NIH（NATIONAL INSTITUTE OF HEALTH）：（美国）全国卫生研究所CLINICAL TRIAL：临床试验ANIMAL TRIAL：动物试验ACCELERATED APPROVAL：加速批准STANDARD DRUG：标准药物INVESTIGATOR：研究人员；调研人员PREPARING AND SUBMITTING：起草和申报SUBMISSION：申报；递交BENIFIT（S）：受益RISK（S）：受害DRUG PRODUCT：药物产品DRUG SUBSTANCE：原料药ESTABLISHED NAME：确定的名称GENERIC NAME：非专利名称PROPRIETARY NAME：专有名称；INN（INTERNATIONAL NONPROPRIETARY NAME）：国际非专有名称NARRATIVE SUMMARY记叙体概要ADVERSE EFFECT：副作用ADVERSE REACTION：不良反应PROTOCOL：方案ARCHIVAL COPY：存档用副本REVIEW COPY：审查用副本OFFICIAL COMPENDIUM：法定药典（主要指USP、NF）USP（THE UNITED STATES PHARMACOPEIA）：美国药典（现已和NF合并一起出版）NF（NATIONAL FORMULARY）：（美国）国家药品集OFFICIAL＝PHARMACOPEIAL= COMPENDIAL：药典的；法定的；官方的AGENCY：审理部门（指FDA）SPONSOR：主办者（指负责并着手临床研究者）IDENTITY：真伪；鉴别；特性STRENGTH：规格；规格含量（每一剂量单位所含有效成分的量）LABELED AMOUNT：标示量REGULATORY SPECIFICATION：质量管理规格标准（NDA提供）REGULATORY METHODOLOGY：质量管理方法（FDA用于考核原料药或药物产品是否符合批准了的质量管理规格标准的整套步骤）REGULATORY METHODS VALIDATION：管理用分析方法的验证（FDA对NDA提供的方法进行验证）Dietary supplement：食用补充品种。
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FDA英语术语大全
FDA是什么意思，FDA得英文全称是什么？
FDA（FOOD AND DRUG ADMINISTRATION）：（美国）食品药品管理局
IND（INVESTIGATIONAL NEW DRUG）：临床研究申请（指申报阶段,相对于NDA而言）；研究中的新药（指新药开发阶段，相对于新药而言，即临床前研究结束）NDA（NEW DRUG APPLICATION）：新药申请
ANDA（ABBREVIATED NEW DRUG APPLICATION）：简化新药申请
EP诉（EXPORT APPLICATION）：出口药申请（申请出口不被批准在美国销售的药品）
TREATMENT IND：研究中的新药用于治疗
ABBREVIATED（NEW）DRUG：简化申请的新药
DMF（DRUG MASTER FILE）：药物主文件（持有者为谨慎起见而准备的保密资料，可以包括一个或多个人用药物在制备、加工、包装和贮存过程中所涉及的设备、生产过程或物品。
只有在DMF持有者或授权代表以授权书的形式授权给FDA，FDA 在审查IND、NDA、ANDA时才能参考其内容）
HOLDER：DMF持有者 CFR（CODE OF FEDERAL REGULATION）：（美国）联邦法规PANEL：专家小组
BATCH PRODUCTION：批量生产；分批生产
BATCH PRODUCTION RECORDS：生产批号记录
POST-OR PRE- MARKET SURVEILLANCE：销售前或销售后监督
INFORMED CONSENT：知情同意（患者对治疗或受试者对医疗试验了解后表示同意接受治疗或试验）
PRESCRIPTION DRUG：处方药
OTC DRUG（OVER—THE—COUNTER DRUG）：非处方药
U．S．PUBLIC HEALTH SERVICE：美国卫生福利部
NIH（NATIONAL INSTITUTE OF HEALTH）：（美国）全国卫生研究所
CLINICAL TRIAL：临床试验
ANIMAL TRIAL：动物试验
ACCELERATED APPROVAL：加速批准
STANDARD DRUG：标准药物
INVESTIGATOR：研究人员；调研人员
PREPARING AND SUBMITTING：起草和申报
SUBMISSION：申报；递交
BENIFIT（S）：受益
RISK（S）：受害
DRUG PRODUCT：药物产品
DRUG SUBSTANCE：原料药
ESTABLISHED NAME：确定的名称
GENERIC NAME：非专利名称
PROPRIETARY NAME：专有名称；
INN（INTERNATIONAL NONPROPRIETARY NAME）：国际非专有名称
NARRATIVE SUMMARY记叙体概要
ADVERSE EFFECT：副作用
ADVERSE REACTION：不良反应
PROTOCOL：方案
ARCHIVAL COPY：存档用副本
REVIEW COPY：审查用副本
OFFICIAL COMPENDIUM：法定药典（主要指USP、 NF）．
USP（THE UNITED STATES PHARMACOPEIA）：美国药典（现已和NF合并一起出版）
NF（NATIONAL FORMULARY）：（美国）国家药品集
OFFICIAL＝PHARMACOPEIAL= COMPENDIAL：药典的；法定的；官方的AGENCY：审理部门（指FDA）
SPONSOR：主办者（指负责并着手临床研究者）
IDENTITY：真伪；鉴别；特性
STRENGTH：规格；规格含量（每一剂量单位所含有效成分的量）
LABELED AMOUNT：标示量
REGULATORY SPECIFICATION：质量管理规格标准（NDA提供）
REGULATORY METHODOLOGY：质量管理方法（FDA用于考核原料药或药物产品是否符合批准了的质量管理规格标准的整套步骤）
REGULATORY METHODS VALIDATION：管理用分析方法的验证（FDA对NDA提供的方法进行验证）
Dietary supplement：食用补充品。