临床试验英语词汇(2018)

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临床试验相关英文及缩写

临床试验相关英文及缩写

35 ALP-Alkaline Phosphatase 碱性磷酸酶 36 TB- Total Bilirubin 总胆红素 37 LDH 乳酸脱氢酶 38 GGT 谷氨酰转氨酶 39 Glucose 葡萄糖 40 Blood Coagulation 凝血 41 PT-Prothrombin Time 凝血酶原时间 42 PT-INR 凝血酶原时间-国际标准化比值 43 APTT 活化部分凝血活酶时间 药物相关 IP-Investigational Product 研究产品 CM -Concomitant Medication 合并用药 Drug Receive 药物接收 Drug Storage 药物储存 Drug Dispense 药物分发 Drug Return 药物返还 Drug Destroy 药物销毁 Quantity 数量 Medication No. 研究药品编号 Packaging 包装 Labeling 标签 Drug Accountability 药物清点 Drug Administration 药物使用 Overdose 药物过量 Dose Reduce 剂量降低 Dose Interrupt 剂量中断(暂停) Dose Discontinuation 剂量终止(完全终止) 不良反应相关 ADR- Adverse Drug Reaction 药物不良反应 AE- Adverse Event 不良事件 SAE Serious Adverse Event 严重不良事件 Seriousness 严重性(性质) Severity 严重程度(程度) Grade 级别 Results in death 导致死亡 Life threatening 危急生命 Requires or prolongs hospitalization 导致或延长住院时间 Congenital anomaly/Birth defect 先天畸形/出生缺陷

临床试验相关词汇中英对照

临床试验相关词汇中英对照

临床试验词汇中英文对照Accuracy 准确度Active control,AC 阳性对照,活性对照Adverse drug reaction,ADR 药物不良反应Adverse event,AE 不良事件Adverse medical events 不良医学事件Adverse reaction 药物不良反应Alb 白蛋白ALD(Approximate Lethal Dose)近似致死剂量ALP 碱性磷酸酶Alpha spending function 消耗函数ALT 丙氨酸氨基转换酶Analysis sets 统计分析的数据集Approval 批准Assistant investigator 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Audit or inspection 稽查/视察Audit report 稽查报告Auditor 稽查员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Blind review 盲态检查Blinding method 盲法Blinding/ masking 盲法,设盲Block 分段Block 层Block size 每段的长度BUN 尿素氮Carryover effect 延滞效应Case history 病历Case report form 病例报告表Case report form/ case record form,CRF 病例报告表,病例记录表Categorical variable 分类变量Cav 平均浓度CD 圆二色谱CL(clearance)清除率Clinical equivalence 临床等效性Clinical study 临床研究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Clinical trial protocol,CTP 临床试验方案Clinical trial/ study report 临床试验报告Cmax 峰浓度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Confidence interval 可信区间Confidence level 置信水平Consistency test 一致性检验Contract research organization,CRO 合同研究组织Contract/ agreement 协议/合同Control group 对照组Coordinating committee 协调委员会Crea 肌酐CRF(case report form)病例报告表Crossover design 交叉设计Cross-over study 交叉研究Css 稳态浓度Cure 痊愈Data management 数据管理Database 建立数据库Descriptive statistical analysis 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-reaction relation 剂量-反应关系Double blinding 双盲Double dummy 双模拟Double dummy technique 双盲双模拟技术Double-blinding 双盲Drop out 脱落DSC 差示扫描热量计Effectiveness 疗效Electronic data capture,EDC 电子数据采集系统Electronic data processing,EDP 电子数据处理系统Emergency envelope 应急信件End point 终点Endpoint criteria/ measurement 终点指标Equivalence 等效性Essential documentation 必须文件Ethics committee 伦理委员会Excellent 显效Exclusion criteria 排除标准Factorial design 析因设计Failure 无效,失败Final point 终点Fixed-dose procedure 固定剂量法Forced titration 强制滴定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Global assessment variable 全局评价变量GLU 血糖Good clinical practice,GCP 药物临床试验质量管理规范Good manufacture practice,GMP 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Group sequential design 成组序贯设计Health economic evaluation,HEV 健康经济学评价Hypothesis test 假设检验Hypothesis testing 假设检验International Conference of Harmonization,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Inclusion criteria 入选标准Independent ethics committee,IEC 独立伦理委员会Information consent form,ICF 知情同意书Information gathering 信息收集Informed consent,IC 知情同意Initial meeting 启动会议Inspection 视察/检查Institution inspection 机构检查Institution review board,IBR 机构审查委员会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Investigator 研究者Investigator's brochure,IB 研究者手册IR 红外吸收光谱Ka 吸收速率常Last observation carry forward,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Logic check 逻辑检查LOQ (Limit of Quantitation)定量限LOCF,Last observation carry forward 最近一次观察的结转Lost of follow up 失访Marketing approval/ authorization 上市许可证Matched pair 匹配配对Missing value 缺失值Mixed effect model 混合效应模式Monitor 监查员Monitoring 监查Monitoring report 监查报告MRT 平均滞留时间MS 质谱MS-MS 质谱-质谱联用MTD(Maximum Tolerated Dose)最大耐受剂量Multicenter trial 多中心试验Multi-center trial 多中心试验New chemical entity,NCE 新化学实体New drug application,NDA 新药申请NMR 核磁共振谱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ODR 旋光光谱Open-blinding 非盲Open-label 非盲Optional titration 随意滴定Original medical record 原始医疗记录Outcome 结果Outcome assessment 结果指标评价Outcome measurement 结果指标Outlier 离群值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Primary endpoint 主要终点Primary variable 主要变量Principal investigator 主要研究者Principle investigator,PI 主要研究者Product license,PL 产品许可证Protocol 试验方案Protocol 试验方案Protocol amendment 方案补正Quality assurance unit,QAU 质量保证部门Quality assurance,QA 质量保证Quality control,QC 质量控制Query list,query form 应用疑问表Randomization 随机化Randomization 随机Range check 范围检查Rating scale 量表Regulatory authorities,RA 监督管理部门Replication 可重复RSD 日内和日间相对标准差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 样本含量Sample size 样本量,样本大小Scale of ordered categorical ratings 有序分类指标Secondary variable 次要变量Sequence 试验次序Serious adverse event,SAE 严重不良事件Serious adverse reaction,SAR 严重不良反应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Single-blinding 单盲Site audit 试验机构稽查SOP 试验室的标准操作规程Source data verification,SDV 原始数据核准Source data,SD 原始数据Source document,SD 原始文件Specificity 特异性Sponsor 申办者Sponsor-investigator 申办研究者Standard curve 标准曲线Standard operating procedure,SOP 标准操作规程Statistic 统计量Statistical analysis plan 统计分析计划Statistical analysis plan 统计参数计划书Statistical analysis plan,SAP 统计分析计划Statistical model 统计模型Statistical tables 统计分析表Stratified 分层Study audit 研究稽查Subgroup 亚组Sub-investigator 助理研究者Subject 受试者Subject diary 受试者日记Subject enrollment 受试者入选Subject enrollment log 受试者入选表Subject identification code,SIC 受试者识别代码Subject recruitment 受试者招募Subject screening log 受试者筛选表Superiority 检验Survival analysis 生存分析SXRD 单晶X-射线衍射System audit 系统稽查T1/2 消除半衰期Target variable 目标变量T-BIL 总胆红素T-CHO 总胆固醇TG 热重分析TLC、HPLC 制备色谱Tmax 峰时间TP 总蛋白Transformation 变量变换Treatment group 试验组Trial error 试验误差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Unblinding 揭盲Unblinding 破盲Unexpected adverse event,UAE 预料外不良事件UV-VIS 紫外-可见吸收光谱Variability 变异Variable 变量Visual analogy scale 直观类比打分法Visual check 人工检查Vulnerable subject 弱势受试者Wash-out 清洗期Washout period 洗脱期Well-being 福利,健康临床采血相关词汇Intravenous injection(IV) 静脉注射Intravenous drip/Intravenously guttae(iv gtt)静脉滴注intramscular injection(IM) 肌内注射intradermal injections 皮内注射subcutaneous injections(SC)皮下注射disposable sterile injector 一次性无菌注射针injection set注射器disposable venous infusion needle一次性静脉输液针disposable infusion set 一次性使用输液器blood transfusion set输血器infusion bag液袋urine drainage bag集尿袋blood bag血袋medical catheter医用导管stainless steel needle不锈钢医用针管blood taking needle/ blood collection needle采血针Needle Holder 持针器Blood samples血样样本sample drawing/collection 采血/抽血needles 针vacutainer needles真空采血针tubes导管vacutainer tubes 真空管vacutainer holder 真空持针器tourniquet 止血带disinfection swabs 消毒海绵micropore tapedental rollsadhesive dressing 胶布敷料rubber gloves 橡皮手套pillow 枕头stopper 塞子(采血管的塞子)vacuum tubes真空管non-vacuum tubes 非真空管needle disposal box 穿刺针处理盒(利器处理盒)transfer and storage tubes 转移和存储管pipette 吸管吸液管移液管disposable pipettes一次性使用吸管centrifuge离心机swinging bucket rotor 浮桶式转头、吊桶式转头timer 计时器racks for tubes 试管架identification codes识别码mark/label the tubes标记导管freeze冷冻refrigerator 冰箱freezer 冰箱冷冻机Serum Separation Tube 血清分离试管Serum血清Plasma血浆whole blood 全血be inverted 倒垂的倒置的clot 凝块凝结Coagulate 凝固凝结clotting time 凝血时间minimally 最低限度地最低程度地maximally 最高限度地最高程度地Separation of serum or plasma 分离血清或血浆Hemolysis 溶血hemolyzed samples 溶血样本assays 含量测定analysis 分析(名词)analyze 分析(动词)analyzing 分析(动名词)non-frozen samples 非冷冻样本chemistry laboratories化学实验室Analytical procedures 分析程序Qualification 资质资格Personnel in the laboratory 实验室人员Field personnel 现场工作人员Internal quality control 内部质量控制External quality control 外部质量控制Hepatitis B 乙肝Hepatitis C 丙肝Positive 阳性Negative 阴性Measurement 测量pulse rate 脉搏Blood pressure 血压systolic blood pressure 收缩压diastolic blood pressure 舒张压hypertensives 高血压hypotension 低血压antihypertensive drug 抗高血压药mercury sphygmomanometer 水银式血压计mercury column 水银柱serum total cholesterol 血清总胆固醇lipid lowering drug 降脂药Obesity 肥胖症Blood Glucose 血糖BMI (body mass index) 体重指数Overweight 超重sample size 样本大小statistically 统计上地,统计地statistical precision 统计精度sub-groups亚群Recruitment招募Ethical 伦理的道德的Legal 法律的合法的Data in electronic format 电子版数据back-up data 备查资料常用临床医学英文术语cough 咳嗽asthma 哮喘pneumonia 肺炎heart disease 心脏病arrhythmia 心律不齐indigestion 消化不良gastritis 胃炎appendicitis 盲肠炎hepatitis 肝炎dermatitis皮炎freckle/ephelis 痣,雀斑acne 粉刺flu 流感diarrhoea 痢疾quarantine 检疫vaccinate 打疫苗endemic 水土不服relapse 复发症casualty急症stupor 昏迷sprain 扭伤scalding 烫伤graze 擦伤scratch 搔挠trauma 外伤bruise 淤伤fracture骨折dislocation 脱臼tinnitus耳鸣trachoma沙眼colour blindness 色盲nearsightedness/myopia近视astigmatism 散光gingivitis 牙龈炎cavity 龋齿fever 发烧discomfort/disorder 不适malnutrition 营养不良incubation 潜伏期asthenia 虚弱poisoning 中毒fatigue 疲劳heat stroke 中暑itching 发痒ache/pain 痛tetanus 破伤风night sweat 盗汗chill 打冷颤pale 脸色发白shuddering 发抖inflammation 炎症acute 急症chronic 慢性病congenital 先天性病nausea恶心vomit 呕吐diseases 疾病acute diseases 急性病advanced diseases 病沉重期,晚期疾病chronic diseases慢性病communicable diseases 传染病complicating diseases 并发病congenital diseases 先天性疾病acquired diseases 后天性疾病contagious diseases接触性传染病endemic diseases 地方病epidemic diseases 流行病functional diseases 机能病、官能病infectious diseases 传染病inherited diseases 遗传病malignant diseases恶性病nutritional diseases 营养病occupation diseases 职业病organic diseases 器质性病paroxysmal diseases 阵发性病periodical diseases 周期病primary(principal)diseases原发(主导)病secondary diseases 继发病sexual(venereal, social)diseases 性病terminal diseases 绝症wasting diseases 消耗性疾病chief complaint 主诉clinical manifestation 临床表现delivery history 分娩史etiology病因学family history 家族史history, medical history 病史precipitating(induced)诱因marital status婚姻状况menstrual history 月经史menarche 初潮menopause闭经past history既往史pathogenesis 发病机制personal history 个人史symptoms 症状cardinal symptom 主要症状classical symptom 典型症状concomitant symptom 伴发症状constitutional(systemic)symptom 全身症状indirect symptom 间接症状induced symptom 诱发症状local symptom 局部症状mental symptom精神症状symptom-complex (syndrome)symptom 综合症,症候群signs体征antecedent 前驱征assident (accessory)副征commemorative 后遗症sign of death 死征diagnostic诊断征sign of disease 病征subjective 自觉征,主观征vein sign静脉征vital sign 生命体征body length (height of the body)身高body weight 体重barrel chest 桶状胸cachexia 恶病质compulsive position 被动体位critical facies 病危面容emaciation 消瘦enophthalmos 眼球下陷entropion 睑内翻exophthalmos 眼球突出flushed face 面色潮红gain (loss)in weight 增加(减轻)体重lock-jaw 牙关紧闭lordosis 脊柱前凸nasal ala flap 鼻翼扇动nystagmus 眼震obesity 肥胖pallor 苍白scolisis 脊柱侧凸agitation 焦急不安debility, weakness 虚弱diaphoresis 出汗,大量出汗dizziness, vertigo 眩晕lassitude, fatigue 无力,倦怠malaise 不适night sweat 盗汗numbness 麻木rigor, chill 寒冷,发冷perspiration, sweating 出汗pruritus, itching 痒,somasthenia 躯体无力tingling 麻刺感abscess 脓肿acidosis 酸中毒adhesion 粘连alkalosis 碱中毒allergy 过敏coagulation defect 凝血不良congestion 充血dehydration 脱水distention 膨胀edema 水肿embolism 栓塞,栓塞形成fluid and electrolyte imbalance 水电解质紊乱gangrene 坏疽hematoma 血肿hemorrhage, bleeding 出血infarction 梗塞,梗死infection 传染inflammation 炎症ketoacidosis 酮酸中毒metastasis 转移perforation 穿孔necrosis 坏死shock 休克response 反应,应答reaction 反应,感应thrombosis 血栓形成ulceration 溃疡fever, pyrexia 发烧,发热continuous fever 稽留热intermittent fever 间歇热low-grade fever 低热remittent fever 驰张热relapsing fever 回归热pain 痛burning pain 灼痛chest(flank,…)pain 胸(胁腹…)痛cramp-like pain 痉挛性痛dull, diffused pain 弥漫性钝痛pleuritic pain 胸膜炎性痛radiating pain (pain radiating to…)放射性痛(放射到…疼痛)angina 绞痛cardiac angina 心绞痛backache 背痛colic 绞痛,急腹痛earache 耳痛headache 头痛neuralgia 神经痛migraine 偏头痛rebound tenderness 反跳痛somatalgia 躯体痛sore throat 咽喉痛stomachache 胃痛toothache 牙痛bloody sputum 带血的痰cough 咳嗽dry cough 干咳expectoration 咳痰expectoration of blood 咳血hemoptysis 咳血anoxia 缺氧apnea 呼吸暂停,窒息asthma 气喘,哮喘Cheyne Stokes respiration 切-斯氏呼吸,潮式呼吸dyspnea 呼吸困难hyperpnea hyperventilation 过度呼吸,换气过度hypopnea 呼吸不全,呼吸浅表hypoxia 低氧,缺氧orthopnea 端坐呼吸respiratory arrest 呼吸停止suffocation 窒息tachypnea 呼吸急促fetid breath 口臭fruity breath 呼吸有水果味arrhythmia 心律失常,心律不齐atelectasis 肺不张,肺膨胀不全cardiac arrest 心搏骤停cardiac hypertrophy 心脏肥大cyanosis 发绀,青紫distension of jugular vein 颈静脉怒张extrasystole 期外收缩gallop rhythm 奔马律hemopleura 血胸hepatojugular reflux 肝颈静脉回流hypovolemia (循环)血容量减少palpitation 心悸tachycardia 心动过速pneumothorax 气胸thrill 震颤absent breath sounds 呼吸音消失dull sound 浊音hyperresonant 鼓音rale 啰音rhonchus, rhonchi 鼾音,干啰音wheeze 哮鸣音anorexia, loss of appetite 食欲不振,厌食dysphagia 吞咽困难eructation 嗳气belching 嗳气flatulence 气胀flatus 肠胃气,屁gaseous distention 胃胀气hematemesis 呕血hiccough, hiccup 打呃,呃逆nausea 恶心pyrosis 胃灼热regurgitation 反胃,回流thirsty 口渴vomiting 呕吐anal fissure, crack in the anal canal 肛裂ascites 腹水board-like rigidity of the abdomen 板状腹decreased tactile fremitus 触觉性震颤减弱exophageal varices 食管静脉曲张fistula 瘘,瘘管hemorrhoid 痔hernia 疝hepatomegaly 肝肿大intussusception 肠套叠jaundice 黄疸muscle guarding, defence of the abdominal wall 腹壁肌卫peristalsis 蠕动loss of peristalsis 蠕动消失mass peristalsis 总蠕动retrograde (reversed)peristalsis 逆蠕动prolapse 脱垂prolapse of anus 脱肛rectal prolapse 直肠脱垂,脱肛volvulus 肠扭转calculus 结石,石biliary calculus 胆结石vesical calculus 膀胱结石constipation 便秘defecation 排便diarrhea 腹泻incontinence of feces 大便失禁hematochezia 便血fecal impaction 大便嵌塞occult blood 潜血painful straining with defecation 排便痛性牵动clay colored stools 陶土色便dark, granular/coffee ground emesis 咖啡样呕吐物fecal vomiting, stercoraceous vomiting 呕粪,吐粪foul fatty stools, steatorrhea 恶臭脂肪便,脂肪痢scanty and hard stools 便少而硬tarry (black)stools 柏油样便anuria 无尿burning sensation no urination 排尿时的灼烧感dysurea 排尿困难,尿痛enuresis, bed wetting 遗尿frequency of urination 尿频micturation 排尿uresis, urination, voiding 排尿nocturia 夜尿oliguria 少尿polyuria 多尿tenesmus 里急后重vesical tenesmus 排尿时里急后重uremia coma 尿毒症昏迷urgency of urination 尿急urinary incontinence 尿失禁aciduria 酸尿chyluria 乳糜尿cylindruia 管型尿glycosuria 糖尿hematuria 血尿ketonuria 酮尿pneumatinuria 气尿proteinuria 蛋白尿pyuria 脓尿amenorrhea 经闭,无月经dysmenorrhea 痛经menorrhagia 月经过多lochia 恶露menorrhea 行经,月经过多menstruation 月经uterine contraction 子宫收缩blotch 斑点bruise 挫伤,青肿acne 痤疮,粉刺desquamation 脱皮,脱屑ecchymosis 瘀斑loss of skin turgor 失去皮肤充盈nevus 痣papule 丘疹petechia 瘀点,瘀斑pigmentation 色素沉着pustule 脓疱purpura 紫癫red nodule 红结节roseola 玫瑰疹scar 伤疤senile plaque 老人斑spider anaioma 蛛形痣subcutaneous nodule 皮下结节urticaria 荨麻疹vesicle 小水疱vitiligo 白斑blindness 失明blurred vision, visual disturbance 视力模糊impaired vision 视力下降lacrimation 流泪papilledema 视神经乳头水肿photophobia 畏光,羞明retinal detachment 视网膜脱离deafness 聋hearing loss 听力丧失tinnitus 耳鸣epistaxis, nasal bleeding 鼻出血impaired smelling 嗅觉障碍nasal discharge 鼻涕nasal obstruction 鼻塞sneeze 喷嚏snore 打鼾aphonia, loss of voice 失音症hoarseness 嘶哑gum bleeding 齿龈出血herpes labialis 唇疱疹,感冒疮Koplik's spots 科普利克斑lead line of the gum 龈铅线salivation, drooling 流口水straw-berry tongue 草莓舌tremulous tongue 舌震颤atrophy 萎缩contracture 挛缩deformity 畸形,变形dislocation 脱位fracture 骨折closed (simple)fracture 无创骨折,单纯性骨折comminuted fracture 粉碎性骨折compound fracture 哆开(开放性)骨折knock-knee 膝外翻opisthotonos 角弓反张prosthesis 假体spasm 痉挛tetany (肌)强直,手足抽搦wrist drop 腕下垂aphasia 失语ataxia 共济失调coma 昏迷consciousness 知觉,意识convulsion 抽搐,惊厥delirium 谵妄delusion 妄想faint 昏厥hallucination 幻觉hemiplegia 偏瘫increased intracranial pressure 颅内压增高insanity 精神错乱loss of orientation 定向丧失mania 躁狂memory defects, amnesia 记忆缺损,遗忘症paraplegia 截瘫,下身麻痹projectile vomiting 喷射性呕吐somnolence, (lethargy)昏睡,嗜睡stupor 木僵,昏呆tetraplegia 四肢瘫痪unconsciousness 失去知觉yawning 打哈欠crisis 危象cerebral (febrile, hematic, hemolytic,hypertensiv e, thyrotoxic, ……)crisis脑(热、血性、溶血、高血压、甲状腺中毒…)危象failure 衰竭,故障centra(circulatory, cardiac, myocardiac, peripheral, congestive, renal, respiratory)failure中枢(循环、心力、心肌、周围循环、充血性、肾、呼吸…)衰竭diagnosis诊断auscultation 听诊inspection 视诊palpation触诊percussion 叩诊laboratory examination 实验室检查physical examination 体格检查rectal (vaginal)touch 直肠(阴道)指诊impression 印象tentative diagnosis 暂定诊断differential diagnosis 鉴别诊断final diagnosis 最后诊断prognosis 预后prescription 处方incubation (latent)period 潜伏期prodromal stage 前驱期incipient stage 初期quiescent stage 静止期alleviation 减轻,缓和remission 缓解attack 发作convalescence (recovery)stage 恢复期rehabilitation 康复relapse 复发sudden death 猝死moribund 濒死的course of the disease 病程course of the treatment 疗程indication 适应症,指征complication 并发症contraindication 禁忌症side-effect 副作用sequel (sequela), after effect 后遗症therapies 治疗方法acupuncture therapy 针刺疗法block therapy 封闭疗法chemical therpy (chemo-therapy)化学疗法combined therapy 综合疗法conservative therapy 保守疗法constitutional therapy 全身疗法dietetic therapy 饮食疗法operative treatment 手术疗法palliative treatment, alleviative treatment 姑息疗法physical therapy 物理疗法psychotherapy 精神疗法radical treatment 根治radio-therapy 放射性疗法supporting treatment 支持疗法symptomatic treatment对症疗法cardiac massage 心脏按摩cardiac pacing 心脏起博electrotherapy 电疗法electroshock treatment 电休克疗法hemodialysis 血液透析hyperbaric therapy 高压氧疗法insulin-shock treatment 胰岛素休克疗法light therapy 光疗法Urine Analyzer 尿液分析仪blood sugar(glucose )analyzer血糖分析仪test strip 测试条reagent 试剂Semi-automatic Biochemical Analyzer半自动生化分析仪Automatic Blood Cell Analyzer全自动血细胞分析仪Urine sediments analyzer尿沉渣Bio-safety Cabinet 生物安全柜Incubator培养箱High Frequency Electrotome 高频电刀shadowless lamp无影灯High speed refrigerated centrifuge高速冷冻离心机hot air sterilizer热空气消毒箱microbiological incubator微生物培养箱Halogen light 卤素灯needle destroyer针头销毁器automatic packer自动纸塑包装机scalp vein set头皮针uniprocessor version单机版network version网络版macromolecule-solvent 高分子溶解的macromolecule cold accumulation 高分子蓄冷cold treatment冷疗法ice pack冰袋eyeshade 眼罩Medical injection pump医用灌注泵lithotrite 碎石机extracorporeal shock wave lithotrite体外冲击碎石机Ballistic intracroporeal lithotrite 气压冲击体内碎石机Laparoscope 腹腔镜Urology 泌尿外科kidney stones 肾结石Multi-parameter monitor, 多参数监护仪maternal monitor/fetal monitor母亲/胎儿监护仪ICU monitor 重症监护仪anesthetic equipment 麻醉机respirator呼吸机electronic colposcope 电子阴道镜smog absorber烟雾吸收器digital film room 数字胶片室Permanent Magnet Open Magnetic Resonance system 永磁开放式磁共振系统Ultrasonic Color Doppler Diagnostic system彩色超声多普勒诊断系统Mobile CT system 移动CT系统X-ray Mammary Machine 乳腺X线机Mammography乳腺high precision Stereotaxic 高精度脑立体定向仪portable Type-B ultrasonic 便携式B超Sterilization and Disinfection Equipment消毒灭菌设备Radiotherapeutic equipment.放射疗法设备pharmaceutical equipments.制药设备horizontal pressurized steam sterilizer普通卧式压力蒸汽灭菌器medical electronic linear accelerator医用电子直线加速器high frequency X-rays diagnostic machine高频X射线诊断机simulated positioner模拟定位机high frequency mobile X-rays machine高频移动X射线机医疗卫生人员职衔职称主任医师(讲课):Professor of Medicine主任医师(医疗):Professor of Treatment儿科主任医师:Professor of Paediatrics主治医师:Doctor-in-charge外科主治医师:Surgeon-in-charge内科主治医师:Physician-in-charge眼科主治医师:Oculist-in-charge妇科主治医师:Gynaecologist-in-charge牙科主治医师:Dentist-in-charge医师:Doctor医士:Assistant Doctor主任药师:Professor of Pharmacy主管药师:Pharmacist-in-charge药师:Pharmacist药士:Assistant Pharmacist主任护师:Professor of Nursing主管护师:Nurse-in-charge护师:Nurse Practitioner护士:Nurse主任技师:Senior Technologist主管技师:Technologist-in-charge技师:Technologist技士:Technician常用抗菌药物青霉素类青霉素(G) Penicillin(G) Benzylpenicillin, 苄青霉素, 盘尼西林青霉素V Penicillin V Phenoxymethylpenicillin, Blinvan, Ospen, 苯氧甲基青霉素苄星青霉素Benzathine Penicillin 长效西林, 长效青霉素, 比西林, LPG, 苄星青氨苄西林Ampicillin 安比西林, 氨苄青霉素, 安必仙, 安必林, 安比林阿莫西林Amoxicillin 特力士, 弗来莫星, 羟氨苄青霉素, 益萨林, 阿莫仙, 安福喜, 本原莫星巴氨西林Bacampicillin 美洛平, 氨卡西林, 氨苄青霉素甲戊酯阿洛西林Azlocillin 阿乐欣, 咪氨苄西林, 氧咪苄青霉素, Azlin美洛西林Mezlocillin 天林, Baypen, Mezlin, Baycipen替卡西林Ticarcillin 羧噻吩青霉素, 的卡西林, Nonapen, Ticarpen酞氨西林Talampicillin 氨苄青霉素酞酯, 酞氨苄青霉素, 酞氨苄西林, TAPC, Talpen夫苄西林Furbenicillin 呋脲苄青霉素, 呋苄青霉素, 呋氨西林, 呋喃酰脲苄青霉素氟氯西林Flucloxacillin 氟氯苯唑青霉素, 氟沙星, 福氯平, Floxapen羧苄西林Carbenicillin 羧苄青霉素, 卡比西林, 羧苄青阿扑西林Aspoxicillim 天冬羟氨青霉素, Doyle, ASPC匹氨西林Pivampicillin 氨苄西林酯, 匹凡西林, 匹呋西林, 吡呋氨卡西林双氯西林Dicloxacillin 双氯青, Dynapen, Consaphyl, Stampen, Diflor甲氧西林Meticillin 新青霉素Ⅰ, 美替西林, Azapen, Penysol苯唑西林钠Oxacillin Sodium 新青霉素Ⅱ, 苯唑青霉素钠, 苯甲异噁唑青霉素奈夫西林Nafcillin 新青霉素Ⅲ, 乙氧萘青霉素匹美西林Pivmecillinam 氮卓咪青霉素双酯, Celfuron, Melysin仑氨苄西林Lenampicillin Varacillin, Takacillin美西林Mecillinam Selexidleo, Selexid, Coactin, Amdinocillin, 氮卓脒青霉素哌拉西林钠Piperacillin Sodium 氧哌嗪青霉素, 哔哌西林, 哌氨苄青霉素Avocin, Orocin, Pipril氯唑西林钠Cloxacillin Sodium 邻氯青霉素钠, 氯唑青, Orbenin阿帕西林钠Apalcillin Sodium 萘啶青霉素钠, APPC, Lumota, Elumota, Palcin磺苄西林钠Sulbenicillin Sodium 磺苄青霉素钠, 卡他西林, 格达西林Sulfocillin, Lilacillin, Kedacillin青霉素V钾Phenoxymethylpenicillin Potassiume 6–苯氧乙酰胺基青霉烷酸钾, Cillaphen Distaquaine VK, Compocillin VK, Dowpen VK Cilicaine VK, Apopen, Biopen海他西林钾Hetacillin Potassium 缩酮氨苄青霉素钾, Etacillin, Veisapen卡茚西林钠Carindacillin Sodium Carbenicillin Indanyl Sodium, Geopen, Geocillin 治平霉素替莫西林二钠Temocillin Disodium Temopen头孢菌素类第一代头孢噻吩钠Cefalotin Sodium 先锋Ⅰ号, 头孢金素, 噻孢霉素, CET头孢噻啶Cefaloridine 先锋Ⅱ号, 头孢利素, CER, Kafspor头孢来星Cefaloglycine 先锋Ⅲ号, 头孢甘酸, Kafocin, Kefglycin头孢氨苄Cefalexin 先锋Ⅳ号, 苯甘孢霉素, 头孢力新, CEX头孢唑啉钠Cefazolin Sodium 先锋Ⅴ号, 塞福宁, 西华乐林, 先锋啉, 凯复唑Cefalin, CEX, Cefamedin, Kefzol, Cramaxin头孢拉定Cefradine 先锋Ⅵ号, 头孢雷定, 头孢瑞丁, 头孢环已烯,泛捷复, Velosef, CED, 塞福定头孢乙腈Cefacetrile 先锋Ⅶ号, 头孢腈甲, 头孢赛曲头孢匹林Cefapirin 先锋Ⅷ号, 头孢吡硫, Ceta-Dri头孢硫脒Cefathiamidine 先锋18, 吡脒头孢头孢克洛Cefaclor 赐福乐素, 新达乐, 头孢氯氨苄, Ceclor, 希刻劳,头孢克罗, 可福乐, 氯头孢菌素, CCL头孢羟氨苄Cefadroxil Cefadril, Kefroxil, 羟氨苄头孢菌素, 欧意, CDX,Duracef, Bidocef, Cefamx头孢沙定Cefroxadine 头孢环烯氨, ORASPON, CGP-9000, CXD头孢罗齐Cefprozil 头孢丙烯, Cefzil头孢替唑Ceftezole 特子社复, Tezacef, Alomen第二代头孢呋辛钠Cefuroxime Sodium 头孢呋肟, 赐福乐信, 舒贝洛, 西力欣, 特力欣, 明可欣, CXM, Zinacef, Monacef, Ketocef, Furex Kesiut, Supero头孢替安Cefotiam 噻乙胺唑头孢菌素, 头孢噻乙胺唑, 泛司博林, 泛司颇灵, Pansparin, Halospor, CTM头孢呋辛酯Cefuroxime Axetil 头孢呋肟酯, 新菌灵, 西力达, 头孢呋新乙酰乙酯Zinnat头孢西丁Cefoxitin 头孢氧唑, 甲氧头霉噻吩, 噻吩甲氧头孢菌素, 美福仙, 甲氧头霉噻吩, CXT, CFX头孢尼西二钠Cefonicid Disodium 铭乐希, Monocid, Cefonicid, Cefodie, Cefol头孢孟多Cefamandole 头孢羟唑, 羟苄四唑头孢菌素, Mandolkef, CMT, Cefadole, Mandol头孢美唑钠Cefmetazole Sodium 先锋美他醇, 氰唑甲氧头孢菌素, 头孢氰四唑,头孢美他唑, CEFMETAZON, CMZ, Cemetol头孢布宗Cefbuperazone 头孢拉宗, Keiperazon, Tomiporan, Cefobutazine, CBPZ 头孢雷特Ceforanide 头孢氨甲苯唑, 头孢苄胺四唑, 氨苄唑头孢菌素Precef第三代头孢地尼Cefdinir Cefzon头孢布坦Ceftibuten 头孢布烯, Cedax头孢卡品Cefcapene Pivoxil 头孢卡喷新戊酰氧甲酯, Flomox头孢噻肟钠Cefotaxime Sodium 头孢氨噻肟, 泰可欣, 塞福隆, 菌必灭, 治菌必妥, 凯福隆, 凯复龙, 头孢噻肟, 喜福得, Claforan, CTX头孢曲松钠Ceftriaxone Sodium 头孢三嗪, 头孢泰克松, 罗氏芬, 罗噻嗪, 菌必治, 菌得治, 头孢三嗪噻肟, 泛生舒复, 西华瑞隆, Rocephin, Ro-139904, CTRX 头孢哌酮钠Cefoperazone Sodium 头孢氧哌唑, 先锋必, 头孢必, 达诺欣, 塞福必,Cefobid, T-1551, CPZ头孢他啶Ceftazidime 头孢塔齐定, 头孢羧甲噻肟, 复达欣, 凯复定, Glazidine, Fortaz, Eposerin, Modocin, Fotrum, Tazidime, CTZ, Spectrum, Eposerin, Modocin头孢唑肟Ceftizoxime 头孢去甲噻肟, 益保世灵, 安保速灵, Epocelin CZX, CEFTIZOX头孢克肟Cefixime 头孢烯噻羟肟, 世伏素, 世福素, FK027, Suprax, CFIX , CEFSPAN头孢甲肟Cefmenoxime 头孢氨噻肟唑, 倍司特克, BESTCALL, CMX头孢地嗪Cefodizime 头孢双唑, 莫敌, 莫敌威, Modivid, Timcef头孢匹胺Cefpiramide 先福吡兰, 甲吡唑头孢菌素, 头孢吡胺, CPM,Cefpiran, Sepatren头孢特仑酯Cefteram Pivoxil 头孢特仑新戊酰氧甲酯, 托米仑, 头孢他美酯,富山龙, Tomiron头孢磺吡苄钠Cefsulodin Sodium 头孢磺吡酮, 头孢磺啶钠, 磺吡苄头孢菌素钠,达克舒林, Cefsulodine, Takesulin, CFS, SCE129拉他头孢Latamoxef 羟羧氧酰胺菌素, 拉氧头孢, 头孢拉坦, 噻吗灵Moxalactam, Shiomarin, Moxam, LMOX头孢米诺Cefminox 氨羧甲氧头孢菌素, 美土灵, Meicelin头孢咪唑Cefpimizole Benilan, SPIE, Ajicef头孢替坦二钠Cefotetan Disodium 双硫唑甲氧头孢霉素, Yamatetan, CTT, Cefotan第四代头孢唑喃钠Cefuzonam Sodium Cosmosin, CZON氟氧头孢钠Flomoxef Sodium 氟莫克西, 6315-S头孢匹罗Cefpirome 头孢吡隆, 氨噻肟吡戊头孢其它Β-内酰胺类亚胺培南Imipenem 伊米配能, 亚胺硫霉素, NFT氯曲南Aztreonam 菌克单, 君刻单, 噻肟单酰胺菌素, AZACTAM,Primbactam, Primbactin, SQ-26776氟罗培南Faropenem 福劳派南, Farom苄西林/氯唑西林Ampicillin/Cloxacillin 复方安比西林, 爱罗苏, 氨氯西林, 白罗仙, 淋必清, Pinocine亚胺培南/西司他丁Imipenem/Cilastatin 亚胺硫霉素/西拉司丁, 泰能, TIENAM, PRIMAXIN阿莫西林/氟氯西林Amoxicillin/Flucloxacillin 氟羟西林, 新灭菌, Biflocin, Infectrin三羟阿莫西林/单羟双氯西林Amoxycillin Trihydrate/Dicloxacillin康彼身, 克菌, CompliscanΒ-内酰胺类抗生类+Β-内酰胺酶抑制剂氨苄西林/舒巴坦Ampicillin/Sulbactam 强力安必仙, 舒他西林, 优力新, 新凯兰欣, 舒氨欣, Unasyn, Sultamicillin头孢哌酮/舒巴坦Cefoperazone/Sulbactam 舒普深, 舒哌酮, Sulperazone头孢噻肟/舒巴坦Cefotaxime/Sulbactam 新治菌哌拉西林/他佐巴坦Piperacillin/Tazobactam Tazocin, YP-14阿莫西林/克拉维酸Amoxillin/Clavulanic Acid 安灭菌, 安美汀, 奥格门汀, 安美汀, 阿莫克拉Augmentin, BRL25000替卡西林/克拉维酸Ticarcillin/Clavulanic Acid 泰门汀, 特泯菌, 特美汀, Timentin舒巴坦Sulbactam 舒巴克坦, 陪他美, 青霉烷砜氨基糖甙类链霉素Streptomycin RIMACTANE, RIFAMPINN, ovostrep庆大霉素Gentamycin 庆大霉素C, 瑞贝克, 正泰霉素庆大霉素链Gentamicin Chains 塞透派勒链, Septopal妥布霉素Tobramycin 立可信软膏,点必舒眼药水(妥布+地塞米松)泰星,妥布拉霉素,托普霉素,NEBCIN,Factorb, Brulamycin, Tobra, Nebramycin, Gernebcin, Obracine小诺霉素Micronomicin 小诺米星, 沙加霉素, 相模霉素, Sagamicin, Kw-1062, MCR核糖霉素Ribostamycin 威他霉素, 维生霉素, Vistamycin, Ibistacin大观霉素Spectinomycin 奇霉素, 壮观霉素, 淋必治, 奈毒素, Spectram, 克淋, Trobicin, Kirin阿米卡星Amikacin 丁胺卡那霉素, Amikin, Likacin西索米星Sisomicin 西梭霉素, 西索霉素, 紫苏霉素, Sisomin, Sipeptin奈替米星Netilmicin 乙基西梭霉素, 奈特, 奈替霉素, 乙基西素米星, 立克菌星, 乙基紫苏毒素, Ethylsisomicin, Vectacin, Zetamicn, Certomycin, NETROMYCIN异帕米星Isepamicin 依克沙霉素, HAPA-B, Exacin阿司米星Astromicin 阿司霉素, 福提霉素, 武夷霉素, 强壮霉素FORTIMICIN, Kw-1070, ASTM, Fortimicin地贝卡星Dibekacin 双去氧卡那霉素B, Dideoxykanamycin B, DKB, 达苄霉素, Icacine依替米星Etimicin 悉能磷霉素类磷霉素Fosfomycin 福赐美仙, Phosphonomycin, Fosfocina, FOM磷霉素氨基丁三醇Fosfomycin Tromethamine Monurol喹诺酮类第二代吡哌酸Pipemidic Acid PPA第三代诺氟沙星Nofloxacin 氟哌酸, 淋克星, Fulgram, Noroxin, AM-715 MK-0366, Brazan, Baccidal环丙沙星Ciprofloxacin 悉复欣, 悉普欣, 悉普宁, 丽珠环丙, 特美力,环丙氟哌酸, 健宝灵, CIPRO, Bay-0-9867, Ciprobay, Ciproxin培氟沙星Pefloxacin 培福新, 甲氟哌酸, 倍泰, Peflacine洛美沙星Lomefloxacin 洛威, 罗氟酸, 欣美罗, 多龙, Bareon芦氟沙星Rufloxacin 如氟沙星左旋氧氟沙星Levofloxacin 可乐必妥, 左氟沙星, Cravit依诺沙星Enoxacin 氟啶酸, 福禄马, 复克, FLUMARK, GYRAMID,Flumark氟罗沙星Fleroxacin 复诺定, 多氟哌酸, 喹诺敌, 麦加乐定, 沃尔得FLX, Megelone, Quinodis, Ro-236240, AM-833氧氟沙星Ofloxacin 氟嗪酸, 秦利必妥, 泰利特, 奥复星, 康泰必妥, 竹安新, TARIVID, 赞诺欣, Zanoxin, Oflocin, 泰利得, 正康培氟沙星Pefloxacin 甲氟哌酸, 培氟哌酸, 培福新, 倍宁, Pefalcine。

临床试验英语词汇

临床试验英语词汇

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ANOVA 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。

临床试验常见英语词汇

临床试验常见英语词汇

临床试验常见英语词汇基础词汇Clinical Trial 临床试验Protocol 试验方案Synopsis 摘要Study Objective 研究目的Study Endpoint 研究终点Study Design 研究设计Study Procedure 研究流程Study Completion 研究完成Study Termination 研究终止Baseline 基线Inclusion Criteria 入组标准Exclusion Criteria 排除标准IVRS- Interactive Voice Response System 交互式语音应答系统IWRS- Interactive Web Response System 交互式网络应答系统SDV -Source Data Verification 原始数据核查EDC- Electronic Data Capture 电子数据采集Statistical Methods 统计学方法Single Blinding 单盲Double Blinding 双盲Placebo 安慰剂Placebo Control 安慰剂对照Active Control 阳性对照、活性对照Blank Control 空白对照Blinding/Masking 盲法/设盲Randomized, Double-blind Study 随机对照双盲试验Outcome Assessment 结果评价Multi-center Trial 多中心试验OS-Overall Survival 总生存期PFS- Progression Free Survival 无进展生存期Contract/Agreement 合同/协议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SOP- Standard Operating Procedure 标准操作规程Protocol Amendments 修正案CRF- Case Report Form 病历报告表IB- Investigator’s Brochure 研究者手册ICF- Informed Consent Form 知情同意书QA- Quality Assurance 质量保证QC-Quality Control 质量控制Monitoring 监查Monitor 监查员Audit 稽查Auditor 稽查员Inspection 视察CFDA - China Food and Drug Administration 国家食品药品监督管理局FDA- Food and Drug Administration 美国食品与药品监督管理局ICH- International Conference on Harmonization 国际协调会议IEC Independent Ethics Committee 独立伦理委员会IRB-Institutional Review Board 机构审查委员会Sponsor 申办者CRO -Contract Research Organization 合同研究组织SMO-Site Management Organization 现场管理组织Investigational Site 研究中心Investigator 研究者PI- Principal Investigator 主要研究者SI- Sub-investigator 助理研究者CRC- Clinical Research Coordinator 临床研究协调员Initial Meeting 启动会SIV-Site Initiation Visit 中心启动访视。

临床试验英语词汇

临床试验英语词汇

临床试验常用英语词汇大全基础词汇Clinical Trial 临床试验Protocol 试验方案Synopsis 摘要Study Objective 研究目的Study Endpoint 研究终点Study Design 研究设计Study Procedure 研究流程Study Completion 研究完成Study Termination 研究终止Baseline 基线Inclusion Criteria 入组标准Exclusion Criteria 排除标准IVRS- Interactive Voice Response System 交互式语音应答系统IWRS- Interactive Web Response System 交互式网络应答系统SDV -Source Data Verification 原始数据核查EDC- Electronic Data Capture 电子数据采集Statistical Methods 统计学方法Single Blinding 单盲Double Blinding 双盲Placebo 安慰剂Placebo Control 安慰剂对照Active Control 阳性对照、活性对照Blank Control 空白对照Blinding/Masking 盲法/设盲Randomized, Double-blind Study 随机对照双盲试验Outcome Assessment 结果评价Multi-center Trial 多中心试验OS-Overall Survival 总生存期PFS- Progression Free Survival 无进展生存期Contract/Agreement 合同/协议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SOP- Standard Operating Procedure 标准操作规程Protocol Amendments 修正案CRF- Case Report Form 病历报告表IB- Investigator’s Brochure 研究者手册ICF- Informed Consent Form 知情同意书QA- Quality Assurance 质量保证QC-Quality Control 质量控制Monitoring 监查Monitor 监查员Audit 稽查Auditor 稽查员Inspection 视察CFDA - China Food and Drug Administration 国家食品药品监督管理局FDA- Food and Drug Administration 美国食品与药品监督管理局ICH- International Conference on Harmonization 国际协调会议IEC Independent Ethics Committee 独立伦理委员会IRB-Institutional Review Board 机构审查委员会Sponsor 申办者CRO -Contract Research Organization 合同研究组织SMO-Site Management Organization 现场管理组织Investigational Site 研究中心Investigator 研究者PI- Principal Investigator 主要研究者SI- Sub-investigator 助理研究者CRC- Clinical Research Coordinator 临床研究协调员Initial Meeting 启动会SIV-Site Initiation Visit 中心启动访视受试者相关Subject 受试者Subject Screening Log 受试者筛选表Subject Enrollment Log 受试者入选表Subject Identification Code 受试者识别代码FPI/FSI-First Patient/Subject In 首例受试者入组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Recruitment 招募Screening 筛选Randomization 随机Enrollment 入组Visit 访视Visit Window 访视窗口期Out of Visit Window 超窗Follow Up 随访Withdrawal 脱落Compliance 依从性Wash-out Period 洗脱期Cycle 周期Treatment Allocation 治疗分配Patient File 病人档案Case Record/Medical History 病历SD -Source Data/Document/Documentation 原始数据/文件Subject Diary 受试者日记Demography 人口统计学DOB-Date of Birth 出生日期Race 种族Physical Exam 体格检查Vital Signs 生命体征精品文档Height 身高Weigh 体重Temperature 体温Pulse/Heart rate 脉搏/心率Systolic Blood Pressure 收缩压Diastolic Blood Pressure 舒张压ECG-Electrocardiogram 心电图Chest X-ray 胸部X光Image 影像学实验室相关Laboratory Assessment 实验室评估CS/NCS-Clinical Significant/Non-Clinical Significant 有临床意义/无临床意义Hematology/Blood Routine Test 血液学/血常规Hemoglobin 血红蛋白Platelets 血小板RBC-Red Blood Cell 红细胞WBC-White Blood Cell 白细胞Neutrophils 中性粒细胞Lymphocytes 淋巴细胞Monocytes 单核细胞Eosinophils 嗜酸性粒细胞Basophils 嗜碱性粒细胞Urinalysis 尿液分析Glucose 葡萄糖Ketones 酮体Leukocytes 粒性白细胞Nitrite 亚硝酸盐Bilirubin 胆红素Protein 蛋白Crystals 晶体pH 酸碱度Blood Biochemistry 血液生化Calcium 钙Magnesium 镁Phosphorus 磷Sodium 钠Potassium 钾Chloride 氯Creatinine 肌酐BUN-Blood Urea Nitrogen 尿素氮TP- Total Protein 总蛋白Albumin 白蛋白AST /SGOT 谷草转氨酶/门冬氨酸氨基转移酶ALT/ SGPT 谷丙转氨酶/丙氨酸氨基转移酶ALP-Alkaline Phosphatase 碱性磷酸酶TB- Total Bilirubin 总胆红素LDH 乳酸脱氢酶GGT 谷氨酰转氨酶Glucose 葡萄糖Blood Coagulation 凝血PT-Prothrombin Time 凝血酶原时间PT-INR 凝血酶原时间-国际标准化比值APTT 活化部分凝血活酶时间药物相关IP-Investigational Product 研究产品CM -Concomitant Medication 合并用药Drug Receive 药物接收Drug Storage 药物储存Drug Dispense 药物分发Drug Return 药物返还Drug Destroy 药物销毁Quantity 数量Medication No. 研究药品编号Packaging 包装Labeling 标签Drug Accountability 药物清点Drug Administration 药物使用Overdose 药物过量Dose Reduce 剂量降低Dose Interrupt 剂量中断(暂停)Dose Discontinuation 剂量终止(完全终止)不良事件相关ADR- Adverse Drug Reaction 药物不良反应AE- Adverse Event 不良事件SAE Serious Adverse Event 严重不良事件Seriousness 严重性(性质)Severity 严重程度(程度)Grade 级别Results in death 导致死亡Life threatening 危急生命Requires or prolongs hospitalization 导致或延长住院时间Congenital anomaly/Birth defect 先天畸形/出生缺陷Persistent or significant disability/ incapacity 永久或重大伤残/丧失工作能力Mild 轻度Moderate 中度Severe 重度Safety Assessment/Evaluation 安全评估SUSAR=Serious and Unexpected Suspected Adverse Reaction 严重的非预期疑似相关的药品不良反应Anemia 贫血(血红蛋白降低)Hemoglobin increased 血红蛋白升高Hypertension 高血压Hypotension 低血压Abdominal pain 腹痛Stomach pain 胃痛Constipation 便秘Diarrhea 腹泻Nausea 恶心Vomiting 呕吐Cough 咳嗽Fatigue 疲劳Fever 发热Pain 疼痛Anorexia 厌食症(食欲不振)Headache 头痛Hypersomnia 嗜睡Insomnia 失眠Alopecia 脱发Weight gain 体重增加Weight loss 体重降低Clinical summary report CSR 临床总结报告Statistical analysis report SAR 统计分析报告。

临床研究常用术语英文对照

临床研究常用术语英文对照

临床研究常用术语英文对照Glossary of Common Terms常用术语表Clinical Research临床研究Clinical research is medical research that involves people to test new treatments and therapies.临床研究是涉及人们测试新疗法和疗法的医学研究。

Clinical Trial临床试验A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.前瞻性地将一项或多项人类受试者分配给一项或多项干预措施(可能包括安慰剂或其他对照)的研究,以评估这些干预措施对健康相关的生物医学或行为结局的影响。

Healthy Volunteer健康志愿者(又称:健康受试者)A Healthy volunteer is a person with no known significant healthproblems who participates in clinical research to test a new drug, device, or intervention.健康志愿者是指没有已知重大健康问题的人,他们参与临床研究以测试新药,新设备或新干预措施。

Inclusion/Exclusion Criteria纳入/排除标准Inclusion/Exclusion Criteria are factors that allow someone to participate in a clinical trial are inclusion criteria. Those that exclude or not allow participation are exclusion criteria.纳入/排除标准是允许某人参加临床试验的因素,是纳入标准。

临床试验常用中英文词汇

临床试验常用中英文词汇

SFDA Glossary:GCP,GLP,TRIAL Accuracy 准确度Active control,AC 阳性对照,活性对照Adverse drug reaction,ADR 药物不良反应Adverse event,AE 不良事件Adverse medical events 不良医学事件Adverse reaction 药物不良反应Alb 白蛋白ALD(Approximate Lethal Dose)近似致死剂量ALP 碱性磷酸酶Alpha spending function 消耗函数ALT 丙氨酸氨基转换酶Analysis sets 统计分析的数据集Approval 批准Assistant investigator 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Audit or inspection 稽查/视察Audit report 稽查报告Auditor 稽查员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Blind review 盲态检查Blinding method 盲法Blinding/ masking 盲法,设盲Block 分段Block 层Block size 每段的长度BUN 尿素氮Carryover effect 延滞效应Case history 病历Case report form 病例报告表Case report form/ case record form,CRF 病例报告表,病例记录表Categorical variable 分类变量Cav 平均浓度CD 圆二色谱CL 清除率Clinical equivalence 临床等效应Crossover design 交叉设计Cross-over study 交叉研究Css 稳浓度Cure 痊愈Data management 数据管理Database 建立数据库Descriptive statistical analysis 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-reaction relation 剂量-反应关系Double blinding 双盲Double dummy 双模拟Double dummy technique 双盲双模拟技术Double-blinding 双盲Drop out 脱落DSC 差示扫描热量计Effectiveness 疗效Electronic data capture,EDC 电子数据采集系统Electronic data processing,EDP 电子数据处理系统Emergency envelope 应急信件End point 终点Endpoint criteria/ measurement 终点指标Equivalence 等效性Essential documentation 必须文件Ethics committee 伦理委员会Excellent 显效Exclusion criteria 排除标准Factorial design 析因设计Failure 无效,失败Final point 终点Fixed-dose procedure 固定剂量法Forced titration 强制滴定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Global assessment variable 全局评价变量GLU 血糖Good clinical practice,GCP 药物临床试验质量管理规范Good manufacture practice,GMP 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Group sequential design 成组序贯设计Health economic evaluation,HEV 健康经济学评价Hypothesis test 假设检验Hypothesis testing 假设检验International Conference of Harmonization,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Inclusion criteria 入选标准Independent ethics committee,IEC 独立伦理委员会Information consent form,ICF 知情同意书Information gathering 信息收集Informed consent,IC 知情同意Initial meeting 启动会议Inspection 视察/检查Institution inspection 机构检查Institution review board,IBR 机构审查委员会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Investigator 研究者Investigator's brochure,IB 研究者手册IR 红外吸收光谱Ka 吸收速率常Last observation carry forward,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Logic check 逻辑检查LOQ (Limit of Quantitation)定量限LOCF,Last observation carry forward 最近一次观察的结转Lost of follow up 失访Marketing approval/ authorization 上市许可证Matched pair 匹配配对Missing value 缺失值Mixed effect model 混合效应模式Monitor 监查员Monitoring 监查Monitoring report 监查报告MRT 平均滞留时间MS 质谱MS-MS 质谱-质谱联用MTD(Maximum Tolerated Dose)最大耐受剂量Multicenter trial 多中心试验Multi-center trial 多中心试验New chemical entity,NCE 新化学实体New drug application,NDA 新药申请NMR 核磁共振谱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ODR 旋光光谱Open-blinding 非盲Open-label 非盲Optional titration 随意滴定Original medical record 原始医疗记录Outcome 结果Outcome assessment 结果指标评价Outcome measurement 结果指标Outlier 离群值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Primary endpoint 主要终点Primary variable 主要变量Principal investigator 主要研究者Principle investigator,PI 主要研究者Product license,PL 产品许可证Protocol 试验方案Protocol 试验方案Protocol amendment 方案补正Quality assurance unit,QAU 质量保证部门Quality assurance,QA 质量保证Quality control,QC 质量控制Query list,query form 应用疑问表Randomization 随机化Randomization 随机Range check 范围检查Rating scale 量表Regulatory authorities,RA 监督管理部门Replication 可重复RSD 日内和日间相对标准差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 样本含量Sample size 样本量,样本大小Scale of ordered categorical ratings 有序分类指标Secondary variable 次要变量Sequence 试验次序Serious adverse event,SAE 严重不良事件Serious adverse reaction,SAR 严重不良反应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Single-blinding 单盲Site audit 试验机构稽查SOP 试验室的标准操作规程Source data verification,SDV 原始数据核准Source data,SD 原始数据Source document,SD 原始文件Specificity 特异性Sponsor 申办者Sponsor-investigator 申办研究者Standard curve 标准曲线Standard operating procedure,SOP 标准操作规程Statistic 统计量Statistical analysis plan 统计分析计划Statistical analysis plan 统计参数计划书Statistical analysis plan,SAP 统计分析计划Statistical model 统计模型Statistical tables 统计分析表Stratified 分层Study audit 研究稽查Subgroup 亚组Sub-investigator 助理研究者Subject 受试者Subject diary 受试者日记Subject enrollment 受试者入选Subject enrollment log 受试者入选表Subject identification code,SIC 受试者识别代码Subject recruitment 受试者招募Subject screening log 受试者筛选表Superiority 检验Survival analysis 生存分析SXRD 单晶X-射线衍射System audit 系统稽查T1/2 消除半衰期Target variable 目标变量T-BIL 总胆红素T-CHO 总胆固醇TG 热重分析TLC、HPLC 制备色谱Tmax 峰时间TP 总蛋白Transformation 变量变换Treatment group 试验组Trial error 试验误差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Unblinding 揭盲Unblinding 破盲Unexpected adverse event,UAE 预料外不良事件UV-VIS 紫外-可见吸收光谱Variability 变异Variable 变量Visual analogy scale 直观类比打分法Visual check 人工检查Vulnerable subject 弱势受试者Wash-out 清洗期Washout period 洗脱期Well-being 福利,健康。

临床试验英语词汇

临床试验英语词汇

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。

临床试验英文术语

临床试验英文术语

临床试验英文术语English: A clinical trial is a research study conducted to evaluate a potential new treatment or intervention for a particular medical condition. The purpose of a clinical trial is to gather data on the safety and effectiveness of the treatment in a controlled and regulated environment. Clinical trials are typically divided into four phases, with each phase serving a different purpose in the evaluation process. Phase I trials focus on determining the safety and dosage of the treatment, while Phase II trials examine the preliminary effectiveness of the treatment. Phase III trials compare the new treatment to existing standard treatments, and Phase IV trials are conducted after the treatment has been approved for use to gather additional information on long-term effects and optimal use.Translated content: 临床试验是一项研究,旨在评估对特定医疗条件的潜在新治疗或干预措施。

临床试验中所有涉及到得英文翻译(14页)

临床试验中所有涉及到得英文翻译(14页)

临床试验中所有涉及到的英文翻译(第1页)1. 临床试验(Clinical Trial)2. 研究参与者(Research Participant)3. 研究方案(Protocol)4. 伦理审查委员会(Institutional Review Board, IRB)5. 知情同意书(Informed Consent Form)6. 试验药物(Investigational Product)7. 对照组(Control Group)8. 实验组(Experimental Group)9. 随机化(Randomization)10. 双盲试验(Doubleblind Trial)11. 病例报告表(Case Report Form, CRF)12. 不良事件(Adverse Event)13. 严重不良事件(Serious Adverse Event)14. 数据监控委员会(Data Monitoring Committee, DMC)15. 统计分析计划(Statistical Analysis Plan, SAP)16. 研究终点(Study Endpoint)17. 临床终点(Clinical Endpoint)18. 效力(Efficacy)19. 安全性(Safety)20. 药物代谢动力学(Pharmacokinetics)21. 药物效应动力学(Pharmacodynamics)22. 生物利用度(Bioavailability)23. 生物等效性(Bioequivalence)24. 药物相互作用(Drug Interaction)临床试验中所有涉及到的英文翻译(第2页)25. 研究目标(Study Objective)26. 研究假设(Research Hypothesis)27. 入组标准(Inclusion Criteria)28. 排除标准(Exclusion Criteria)29. 受试者筛选(Subject Screening)30. 基线评估(Baseline Assessment)31. 随访(Followup Visit)32. 疗程(Treatment Regimen)33. 药物剂量(Drug Dosage)34. 给药途径(Route of Administration)35. 药物耐受性(Drug Tolerance)36. 药物依赖性(Drug Dependence)37. 药物副作用(Side Effect)38. 药物毒性(Toxicity)39. 最大耐受剂量(Maximum Tolerated Dose)40. 疗效评估(Efficacy Evaluation)41. 安全性评估(Safety Assessment)42. 生命体征(Vital Signs)43. 实验室检查(Laboratory Tests)44. 影像学检查(Imaging Studies)45. 病历记录(Medical Records)46. 病历报告(Medical Report)47. 病历审查(Medical Review)48. 病历编码(Medical Coding)49. 病历数据库(Medical Database)临床试验中所有涉及到的英文翻译(第3页)50. 研究协调员(Study Coordinator)51. 主要研究者(Principal Investigator)52. 研究团队(Research Team)53. 监查员(Monitor)54. 申办者(Sponsor)55. 研究资助(Research Funding)56. 研究预算(Research Budget)57. 研究合同(Research Contract)58. 知识产权(Intellectual Property)59. 专利保护(Patent Protection)60. 研究注册(Study Registration)61. 临床试验注册(Clinical Trials Registration)62. 公开透明(Transparency)63. 研究结果发表(Publication of Results)64. 数据共享(Data Sharing)65. 隐私保护(Privacy Protection)66. 受试者隐私(Subject Privacy)67. 保密协议(Confidentiality Agreement)68. 信息安全(Information Security)69. 数据保护(Data Protection)70. 研究合规(Research Compliance)71. 法律法规(Regulatory Requirements)72. 质量保证(Quality Assurance)73. 质量控制(Quality Control)74. 标准操作程序(Standard Operating Procedures, SOPs)。

临床试验相关词汇中英对照

临床试验相关词汇中英对照

临床试验词汇中英文对照Accuracy 准确度Active control,AC 阳性对照,活性对照Adverse drug reaction,ADR 药物不良反应Adverse event,AE 不良事件Adverse medical events 不良医学事件Adverse reaction 药物不良反应Alb 白蛋白ALD(Approximate Lethal Dose)近似致死剂量ALP 碱性磷酸酶Alpha spending function 消耗函数ALT 丙氨酸氨基转换酶Analysis sets 统计分析的数据集Approval 批准Assistant investigator 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Audit or inspection 稽查/视察Audit report 稽查报告Auditor 稽查员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Blind review 盲态检查Blinding method 盲法Blinding/ masking 盲法,设盲Block 分段Block 层Block size 每段的长度BUN 尿素氮Carryover effect 延滞效应Case history 病历Case report form 病例报告表Case report form/ case record form,CRF 病例报告表,病例记录表Categorical variable 分类变量Cav 平均浓度CD 圆二色谱CL(clearance)清除率Clinical equivalence 临床等效性Clinical study 临床研究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Clinical trial protocol,CTP 临床试验方案Clinical trial/ study report 临床试验报告Cmax 峰浓度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Confidence interval 可信区间Confidence level 置信水平Consistency test 一致性检验Contract research organization,CRO 合同研究组织Contract/ agreement 协议/合同Control group 对照组Coordinating committee 协调委员会Crea 肌酐CRF(case report form)病例报告表Crossover design 交叉设计Cross-over study 交叉研究Css 稳态浓度Cure 痊愈Data management 数据管理Database 建立数据库Descriptive statistical analysis 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-reaction relation 剂量-反应关系Double blinding 双盲Double dummy 双模拟Double dummy technique 双盲双模拟技术Double-blinding 双盲Drop out 脱落DSC 差示扫描热量计Effectiveness 疗效Electronic data capture,EDC 电子数据采集系统Electronic data processing,EDP 电子数据处理系统Emergency envelope 应急信件End point 终点Endpoint criteria/ measurement 终点指标Equivalence 等效性Essential documentation 必须文件Ethics committee 伦理委员会Excellent 显效Exclusion criteria 排除标准Factorial design 析因设计Failure 无效,失败Final point 终点Fixed-dose procedure 固定剂量法Forced titration 强制滴定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Global assessment variable 全局评价变量GLU 血糖Good clinical practice,GCP 药物临床试验质量管理规范Good manufacture practice,GMP 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Group sequential design 成组序贯设计Health economic evaluation,HEV 健康经济学评价Hypothesis test 假设检验Hypothesis testing 假设检验International Conference of Harmonization,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Inclusion criteria 入选标准Independent ethics committee,IEC 独立伦理委员会Information consent form,ICF 知情同意书Information gathering 信息收集Informed consent,IC 知情同意Initial meeting 启动会议Inspection 视察/检查Institution inspection 机构检查Institution review board,IBR 机构审查委员会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Investigator 研究者Investigator's brochure,IB 研究者手册IR 红外吸收光谱Ka 吸收速率常Last observation carry forward,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Logic check 逻辑检查LOQ (Limit of Quantitation)定量限LOCF,Last observation carry forward 最近一次观察的结转Lost of follow up 失访Marketing approval/ authorization 上市许可证Matched pair 匹配配对Missing value 缺失值Mixed effect model 混合效应模式Monitor 监查员Monitoring 监查Monitoring report 监查报告MRT 平均滞留时间MS 质谱MS-MS 质谱-质谱联用MTD(Maximum Tolerated Dose)最大耐受剂量Multicenter trial 多中心试验Multi-center trial 多中心试验New chemical entity,NCE 新化学实体New drug application,NDA 新药申请NMR 核磁共振谱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ODR 旋光光谱Open-blinding 非盲Open-label 非盲Optional titration 随意滴定Original medical record 原始医疗记录Outcome 结果Outcome assessment 结果指标评价Outcome measurement 结果指标Outlier 离群值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Primary endpoint 主要终点Primary variable 主要变量Principal investigator 主要研究者Principle investigator,PI 主要研究者Product license,PL 产品许可证Protocol 试验方案Protocol 试验方案Protocol amendment 方案补正Quality assurance unit,QAU 质量保证部门Quality assurance,QA 质量保证Quality control,QC 质量控制Query list,query form 应用疑问表Randomization 随机化Randomization 随机Range check 范围检查Rating scale 量表Regulatory authorities,RA 监督管理部门Replication 可重复RSD 日内和日间相对标准差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 样本含量Sample size 样本量,样本大小Scale of ordered categorical ratings 有序分类指标Secondary variable 次要变量Sequence 试验次序Serious adverse event,SAE 严重不良事件Serious adverse reaction,SAR 严重不良反应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Single-blinding 单盲Site audit 试验机构稽查SOP 试验室的标准操作规程Source data verification,SDV 原始数据核准Source data,SD 原始数据Source document,SD 原始文件Specificity 特异性Sponsor 申办者Sponsor-investigator 申办研究者Standard curve 标准曲线Standard operating procedure,SOP 标准操作规程Statistic 统计量Statistical analysis plan 统计分析计划Statistical analysis plan 统计参数计划书Statistical analysis plan,SAP 统计分析计划Statistical model 统计模型Statistical tables 统计分析表Stratified 分层Study audit 研究稽查Subgroup 亚组Sub-investigator 助理研究者Subject 受试者Subject diary 受试者日记Subject enrollment 受试者入选Subject enrollment log 受试者入选表Subject identification code,SIC 受试者识别代码Subject recruitment 受试者招募Subject screening log 受试者筛选表Superiority 检验Survival analysis 生存分析SXRD 单晶X-射线衍射System audit 系统稽查T1/2 消除半衰期Target variable 目标变量T-BIL 总胆红素T-CHO 总胆固醇TG 热重分析TLC、HPLC 制备色谱Tmax 峰时间TP 总蛋白Transformation 变量变换Treatment group 试验组Trial error 试验误差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Unblinding 揭盲Unblinding 破盲Unexpected adverse event,UAE 预料外不良事件UV-VIS 紫外-可见吸收光谱Variability 变异Variable 变量Visual analogy scale 直观类比打分法Visual check 人工检查Vulnerable subject 弱势受试者Wash-out 清洗期Washout period 洗脱期Well-being 福利,健康临床采血相关词汇Intravenous injection(IV) 静脉注射Intravenous drip/Intravenously guttae(iv gtt)静脉滴注intramscular injection(IM) 肌内注射intradermal injections 皮内注射subcutaneous injections(SC)皮下注射disposable sterile injector 一次性无菌注射针injection set注射器disposable venous infusion needle一次性静脉输液针disposable infusion set 一次性使用输液器blood transfusion set输血器infusion bag液袋urine drainage bag集尿袋blood bag血袋medical catheter医用导管stainless steel needle不锈钢医用针管blood taking needle/ blood collection needle采血针Needle Holder 持针器Blood samples血样样本sample drawing/collection 采血/抽血needles 针vacutainer needles真空采血针tubes导管vacutainer tubes 真空管vacutainer holder 真空持针器tourniquet 止血带disinfection swabs 消毒海绵micropore tapedental rollsadhesive dressing 胶布敷料rubber gloves 橡皮手套pillow 枕头stopper 塞子(采血管的塞子)vacuum tubes真空管non-vacuum tubes 非真空管needle disposal box 穿刺针处理盒(利器处理盒)transfer and storage tubes 转移和存储管pipette 吸管吸液管移液管disposable pipettes一次性使用吸管centrifuge离心机swinging bucket rotor 浮桶式转头、吊桶式转头timer 计时器racks for tubes 试管架identification codes识别码mark/label the tubes标记导管freeze冷冻refrigerator 冰箱freezer 冰箱冷冻机Serum Separation Tube 血清分离试管Serum血清Plasma血浆whole blood 全血be inverted 倒垂的倒置的clot 凝块凝结Coagulate 凝固凝结clotting time 凝血时间minimally 最低限度地最低程度地maximally 最高限度地最高程度地Separation of serum or plasma 分离血清或血浆Hemolysis 溶血hemolyzed samples 溶血样本assays 含量测定analysis 分析(名词)analyze 分析(动词)analyzing 分析(动名词)non-frozen samples 非冷冻样本chemistry laboratories化学实验室Analytical procedures 分析程序Qualification 资质资格Personnel in the laboratory 实验室人员Field personnel 现场工作人员Internal quality control 内部质量控制External quality control 外部质量控制Hepatitis B 乙肝Hepatitis C 丙肝Positive 阳性Negative 阴性Measurement 测量pulse rate 脉搏Blood pressure 血压systolic blood pressure 收缩压diastolic blood pressure 舒张压hypertensives 高血压hypotension 低血压antihypertensive drug 抗高血压药mercury sphygmomanometer 水银式血压计mercury column 水银柱serum total cholesterol 血清总胆固醇lipid lowering drug 降脂药Obesity 肥胖症Blood Glucose 血糖BMI (body mass index) 体重指数Overweight 超重sample size 样本大小statistically 统计上地,统计地statistical precision 统计精度sub-groups亚群Recruitment招募Ethical 伦理的道德的Legal 法律的合法的Data in electronic format 电子版数据back-up data 备查资料常用临床医学英文术语cough 咳嗽asthma 哮喘pneumonia 肺炎heart disease 心脏病arrhythmia 心律不齐indigestion 消化不良gastritis 胃炎appendicitis 盲肠炎hepatitis 肝炎dermatitis皮炎freckle/ephelis 痣,雀斑acne 粉刺flu 流感diarrhoea 痢疾quarantine 检疫vaccinate 打疫苗endemic 水土不服relapse 复发症casualty急症stupor 昏迷sprain 扭伤scalding 烫伤graze 擦伤scratch 搔挠trauma 外伤bruise 淤伤fracture骨折dislocation 脱臼tinnitus耳鸣trachoma沙眼colour blindness 色盲nearsightedness/myopia近视astigmatism 散光gingivitis 牙龈炎cavity 龋齿fever 发烧discomfort/disorder 不适malnutrition 营养不良incubation 潜伏期asthenia 虚弱poisoning 中毒fatigue 疲劳heat stroke 中暑itching 发痒ache/pain 痛tetanus 破伤风night sweat 盗汗chill 打冷颤pale 脸色发白shuddering 发抖inflammation 炎症acute 急症chronic 慢性病congenital 先天性病nausea恶心vomit 呕吐diseases 疾病acute diseases 急性病advanced diseases 病沉重期,晚期疾病chronic diseases慢性病communicable diseases 传染病complicating diseases 并发病congenital diseases 先天性疾病acquired diseases 后天性疾病contagious diseases接触性传染病endemic diseases 地方病epidemic diseases 流行病functional diseases 机能病、官能病infectious diseases 传染病inherited diseases 遗传病malignant diseases恶性病nutritional diseases 营养病occupation diseases 职业病organic diseases 器质性病paroxysmal diseases 阵发性病periodical diseases 周期病primary(principal)diseases原发(主导)病secondary diseases 继发病sexual(venereal, social)diseases 性病terminal diseases 绝症wasting diseases 消耗性疾病chief complaint 主诉clinical manifestation 临床表现delivery history 分娩史etiology病因学family history 家族史history, medical history 病史precipitating(induced)诱因marital status婚姻状况menstrual history 月经史menarche 初潮menopause闭经past history既往史pathogenesis 发病机制personal history 个人史symptoms 症状cardinal symptom 主要症状classical symptom 典型症状concomitant symptom 伴发症状constitutional(systemic)symptom 全身症状indirect symptom 间接症状induced symptom 诱发症状local symptom 局部症状mental symptom精神症状symptom-complex (syndrome)symptom 综合症,症候群signs体征antecedent 前驱征assident (accessory)副征commemorative 后遗症sign of death 死征diagnostic诊断征sign of disease 病征subjective 自觉征,主观征vein sign静脉征vital sign 生命体征body length (height of the body)身高body weight 体重barrel chest 桶状胸cachexia 恶病质compulsive position 被动体位critical facies 病危面容emaciation 消瘦enophthalmos 眼球下陷entropion 睑内翻exophthalmos 眼球突出flushed face 面色潮红gain (loss)in weight 增加(减轻)体重lock-jaw 牙关紧闭lordosis 脊柱前凸nasal ala flap 鼻翼扇动nystagmus 眼震obesity 肥胖pallor 苍白scolisis 脊柱侧凸agitation 焦急不安debility, weakness 虚弱diaphoresis 出汗,大量出汗dizziness, vertigo 眩晕lassitude, fatigue 无力,倦怠malaise 不适night sweat 盗汗numbness 麻木rigor, chill 寒冷,发冷perspiration, sweating 出汗pruritus, itching 痒,somasthenia 躯体无力tingling 麻刺感abscess 脓肿acidosis 酸中毒adhesion 粘连alkalosis 碱中毒allergy 过敏coagulation defect 凝血不良congestion 充血dehydration 脱水distention 膨胀edema 水肿embolism 栓塞,栓塞形成fluid and electrolyte imbalance 水电解质紊乱gangrene 坏疽hematoma 血肿hemorrhage, bleeding 出血infarction 梗塞,梗死infection 传染inflammation 炎症ketoacidosis 酮酸中毒metastasis 转移perforation 穿孔necrosis 坏死shock 休克response 反应,应答reaction 反应,感应thrombosis 血栓形成ulceration 溃疡fever, pyrexia 发烧,发热continuous fever 稽留热intermittent fever 间歇热low-grade fever 低热remittent fever 驰张热relapsing fever 回归热pain 痛burning pain 灼痛chest(flank,…)pain 胸(胁腹…)痛cramp-like pain 痉挛性痛dull, diffused pain 弥漫性钝痛pleuritic pain 胸膜炎性痛radiating pain (pain radiating to…)放射性痛(放射到…疼痛)angina 绞痛cardiac angina 心绞痛backache 背痛colic 绞痛,急腹痛earache 耳痛headache 头痛neuralgia 神经痛migraine 偏头痛rebound tenderness 反跳痛somatalgia 躯体痛sore throat 咽喉痛stomachache 胃痛toothache 牙痛bloody sputum 带血的痰cough 咳嗽dry cough 干咳expectoration 咳痰expectoration of blood 咳血hemoptysis 咳血anoxia 缺氧apnea 呼吸暂停,窒息asthma 气喘,哮喘Cheyne Stokes respiration 切-斯氏呼吸,潮式呼吸dyspnea 呼吸困难hyperpnea hyperventilation 过度呼吸,换气过度hypopnea 呼吸不全,呼吸浅表hypoxia 低氧,缺氧orthopnea 端坐呼吸respiratory arrest 呼吸停止suffocation 窒息tachypnea 呼吸急促fetid breath 口臭fruity breath 呼吸有水果味arrhythmia 心律失常,心律不齐atelectasis 肺不张,肺膨胀不全cardiac arrest 心搏骤停cardiac hypertrophy 心脏肥大cyanosis 发绀,青紫distension of jugular vein 颈静脉怒张extrasystole 期外收缩gallop rhythm 奔马律hemopleura 血胸hepatojugular reflux 肝颈静脉回流hypovolemia (循环)血容量减少palpitation 心悸tachycardia 心动过速pneumothorax 气胸thrill 震颤absent breath sounds 呼吸音消失dull sound 浊音hyperresonant 鼓音rale 啰音rhonchus, rhonchi 鼾音,干啰音wheeze 哮鸣音anorexia, loss of appetite 食欲不振,厌食dysphagia 吞咽困难eructation 嗳气belching 嗳气flatulence 气胀flatus 肠胃气,屁gaseous distention 胃胀气hematemesis 呕血hiccough, hiccup 打呃,呃逆nausea 恶心pyrosis 胃灼热regurgitation 反胃,回流thirsty 口渴vomiting 呕吐anal fissure, crack in the anal canal 肛裂ascites 腹水board-like rigidity of the abdomen 板状腹decreased tactile fremitus 触觉性震颤减弱exophageal varices 食管静脉曲张fistula 瘘,瘘管hemorrhoid 痔hernia 疝hepatomegaly 肝肿大intussusception 肠套叠jaundice 黄疸muscle guarding, defence of the abdominal wall 腹壁肌卫peristalsis 蠕动loss of peristalsis 蠕动消失mass peristalsis 总蠕动retrograde (reversed)peristalsis 逆蠕动prolapse 脱垂prolapse of anus 脱肛rectal prolapse 直肠脱垂,脱肛volvulus 肠扭转calculus 结石,石biliary calculus 胆结石vesical calculus 膀胱结石constipation 便秘defecation 排便diarrhea 腹泻incontinence of feces 大便失禁hematochezia 便血fecal impaction 大便嵌塞occult blood 潜血painful straining with defecation 排便痛性牵动clay colored stools 陶土色便dark, granular/coffee ground emesis 咖啡样呕吐物fecal vomiting, stercoraceous vomiting 呕粪,吐粪foul fatty stools, steatorrhea 恶臭脂肪便,脂肪痢scanty and hard stools 便少而硬tarry (black)stools 柏油样便anuria 无尿burning sensation no urination 排尿时的灼烧感dysurea 排尿困难,尿痛enuresis, bed wetting 遗尿frequency of urination 尿频micturation 排尿uresis, urination, voiding 排尿nocturia 夜尿oliguria 少尿polyuria 多尿tenesmus 里急后重vesical tenesmus 排尿时里急后重uremia coma 尿毒症昏迷urgency of urination 尿急urinary incontinence 尿失禁aciduria 酸尿chyluria 乳糜尿cylindruia 管型尿glycosuria 糖尿hematuria 血尿ketonuria 酮尿pneumatinuria 气尿proteinuria 蛋白尿pyuria 脓尿amenorrhea 经闭,无月经dysmenorrhea 痛经menorrhagia 月经过多lochia 恶露menorrhea 行经,月经过多menstruation 月经uterine contraction 子宫收缩blotch 斑点bruise 挫伤,青肿acne 痤疮,粉刺desquamation 脱皮,脱屑ecchymosis 瘀斑loss of skin turgor 失去皮肤充盈nevus 痣papule 丘疹petechia 瘀点,瘀斑pigmentation 色素沉着pustule 脓疱purpura 紫癫red nodule 红结节roseola 玫瑰疹scar 伤疤senile plaque 老人斑spider anaioma 蛛形痣subcutaneous nodule 皮下结节urticaria 荨麻疹vesicle 小水疱vitiligo 白斑blindness 失明blurred vision, visual disturbance 视力模糊impaired vision 视力下降lacrimation 流泪papilledema 视神经乳头水肿photophobia 畏光,羞明retinal detachment 视网膜脱离deafness 聋hearing loss 听力丧失tinnitus 耳鸣epistaxis, nasal bleeding 鼻出血impaired smelling 嗅觉障碍nasal discharge 鼻涕nasal obstruction 鼻塞sneeze 喷嚏snore 打鼾aphonia, loss of voice 失音症hoarseness 嘶哑gum bleeding 齿龈出血herpes labialis 唇疱疹,感冒疮Koplik's spots 科普利克斑lead line of the gum 龈铅线salivation, drooling 流口水straw-berry tongue 草莓舌tremulous tongue 舌震颤atrophy 萎缩contracture 挛缩deformity 畸形,变形dislocation 脱位fracture 骨折closed (simple)fracture 无创骨折,单纯性骨折comminuted fracture 粉碎性骨折compound fracture 哆开(开放性)骨折knock-knee 膝外翻opisthotonos 角弓反张prosthesis 假体spasm 痉挛tetany (肌)强直,手足抽搦wrist drop 腕下垂aphasia 失语ataxia 共济失调coma 昏迷consciousness 知觉,意识convulsion 抽搐,惊厥delirium 谵妄delusion 妄想faint 昏厥hallucination 幻觉hemiplegia 偏瘫increased intracranial pressure 颅内压增高insanity 精神错乱loss of orientation 定向丧失mania 躁狂memory defects, amnesia 记忆缺损,遗忘症paraplegia 截瘫,下身麻痹projectile vomiting 喷射性呕吐somnolence, (lethargy)昏睡,嗜睡stupor 木僵,昏呆tetraplegia 四肢瘫痪unconsciousness 失去知觉yawning 打哈欠crisis 危象cerebral (febrile, hematic, hemolytic,hypertensiv e, thyrotoxic, ……)crisis脑(热、血性、溶血、高血压、甲状腺中毒…)危象failure 衰竭,故障centra(circulatory, cardiac, myocardiac, peripheral, congestive, renal, respiratory)failure中枢(循环、心力、心肌、周围循环、充血性、肾、呼吸…)衰竭diagnosis诊断auscultation 听诊inspection 视诊palpation触诊percussion 叩诊laboratory examination 实验室检查physical examination 体格检查rectal (vaginal)touch 直肠(阴道)指诊impression 印象tentative diagnosis 暂定诊断differential diagnosis 鉴别诊断final diagnosis 最后诊断prognosis 预后prescription 处方incubation (latent)period 潜伏期prodromal stage 前驱期incipient stage 初期quiescent stage 静止期alleviation 减轻,缓和remission 缓解attack 发作convalescence (recovery)stage 恢复期rehabilitation 康复relapse 复发sudden death 猝死moribund 濒死的course of the disease 病程course of the treatment 疗程indication 适应症,指征complication 并发症contraindication 禁忌症side-effect 副作用sequel (sequela), after effect 后遗症therapies 治疗方法acupuncture therapy 针刺疗法block therapy 封闭疗法chemical therpy (chemo-therapy)化学疗法combined therapy 综合疗法conservative therapy 保守疗法constitutional therapy 全身疗法dietetic therapy 饮食疗法operative treatment 手术疗法palliative treatment, alleviative treatment 姑息疗法physical therapy 物理疗法psychotherapy 精神疗法radical treatment 根治radio-therapy 放射性疗法supporting treatment 支持疗法symptomatic treatment对症疗法cardiac massage 心脏按摩cardiac pacing 心脏起博electrotherapy 电疗法electroshock treatment 电休克疗法hemodialysis 血液透析hyperbaric therapy 高压氧疗法insulin-shock treatment 胰岛素休克疗法light therapy 光疗法Urine Analyzer 尿液分析仪blood sugar(glucose )analyzer血糖分析仪test strip 测试条reagent 试剂Semi-automatic Biochemical Analyzer半自动生化分析仪Automatic Blood Cell Analyzer全自动血细胞分析仪Urine sediments analyzer尿沉渣Bio-safety Cabinet 生物安全柜Incubator培养箱High Frequency Electrotome 高频电刀shadowless lamp无影灯High speed refrigerated centrifuge高速冷冻离心机hot air sterilizer热空气消毒箱microbiological incubator微生物培养箱Halogen light 卤素灯needle destroyer针头销毁器automatic packer自动纸塑包装机scalp vein set头皮针uniprocessor version单机版network version网络版macromolecule-solvent 高分子溶解的macromolecule cold accumulation 高分子蓄冷cold treatment冷疗法ice pack冰袋eyeshade 眼罩Medical injection pump医用灌注泵lithotrite 碎石机extracorporeal shock wave lithotrite体外冲击碎石机Ballistic intracroporeal lithotrite 气压冲击体内碎石机Laparoscope 腹腔镜Urology 泌尿外科kidney stones 肾结石Multi-parameter monitor, 多参数监护仪maternal monitor/fetal monitor母亲/胎儿监护仪ICU monitor 重症监护仪anesthetic equipment 麻醉机respirator呼吸机electronic colposcope 电子阴道镜smog absorber烟雾吸收器digital film room 数字胶片室Permanent Magnet Open Magnetic Resonance system 永磁开放式磁共振系统Ultrasonic Color Doppler Diagnostic system彩色超声多普勒诊断系统Mobile CT system 移动CT系统X-ray Mammary Machine 乳腺X线机Mammography乳腺high precision Stereotaxic 高精度脑立体定向仪portable Type-B ultrasonic 便携式B超Sterilization and Disinfection Equipment消毒灭菌设备Radiotherapeutic equipment.放射疗法设备pharmaceutical equipments.制药设备horizontal pressurized steam sterilizer普通卧式压力蒸汽灭菌器medical electronic linear accelerator医用电子直线加速器high frequency X-rays diagnostic machine高频X射线诊断机simulated positioner模拟定位机high frequency mobile X-rays machine高频移动X射线机医疗卫生人员职衔职称主任医师(讲课):Professor of Medicine主任医师(医疗):Professor of Treatment儿科主任医师:Professor of Paediatrics主治医师:Doctor-in-charge外科主治医师:Surgeon-in-charge内科主治医师:Physician-in-charge眼科主治医师:Oculist-in-charge妇科主治医师:Gynaecologist-in-charge牙科主治医师:Dentist-in-charge医师:Doctor医士:Assistant Doctor主任药师:Professor of Pharmacy主管药师:Pharmacist-in-charge药师:Pharmacist药士:Assistant Pharmacist主任护师:Professor of Nursing主管护师:Nurse-in-charge护师:Nurse Practitioner护士:Nurse主任技师:Senior Technologist主管技师:Technologist-in-charge技师:Technologist技士:Technician常用抗菌药物青霉素类青霉素(G) Penicillin(G) Benzylpenicillin, 苄青霉素, 盘尼西林青霉素V Penicillin V Phenoxymethylpenicillin, Blinvan, Ospen, 苯氧甲基青霉素苄星青霉素Benzathine Penicillin 长效西林, 长效青霉素, 比西林, LPG, 苄星青氨苄西林Ampicillin 安比西林, 氨苄青霉素, 安必仙, 安必林, 安比林阿莫西林Amoxicillin 特力士, 弗来莫星, 羟氨苄青霉素, 益萨林, 阿莫仙, 安福喜, 本原莫星巴氨西林Bacampicillin 美洛平, 氨卡西林, 氨苄青霉素甲戊酯阿洛西林Azlocillin 阿乐欣, 咪氨苄西林, 氧咪苄青霉素, Azlin美洛西林Mezlocillin 天林, Baypen, Mezlin, Baycipen替卡西林Ticarcillin 羧噻吩青霉素, 的卡西林, Nonapen, Ticarpen酞氨西林Talampicillin 氨苄青霉素酞酯, 酞氨苄青霉素, 酞氨苄西林, TAPC, Talpen夫苄西林Furbenicillin 呋脲苄青霉素, 呋苄青霉素, 呋氨西林, 呋喃酰脲苄青霉素氟氯西林Flucloxacillin 氟氯苯唑青霉素, 氟沙星, 福氯平, Floxapen羧苄西林Carbenicillin 羧苄青霉素, 卡比西林, 羧苄青阿扑西林Aspoxicillim 天冬羟氨青霉素, Doyle, ASPC匹氨西林Pivampicillin 氨苄西林酯, 匹凡西林, 匹呋西林, 吡呋氨卡西林双氯西林Dicloxacillin 双氯青, Dynapen, Consaphyl, Stampen, Diflor甲氧西林Meticillin 新青霉素Ⅰ, 美替西林, Azapen, Penysol苯唑西林钠Oxacillin Sodium 新青霉素Ⅱ, 苯唑青霉素钠, 苯甲异噁唑青霉素奈夫西林Nafcillin 新青霉素Ⅲ, 乙氧萘青霉素匹美西林Pivmecillinam 氮卓咪青霉素双酯, Celfuron, Melysin仑氨苄西林Lenampicillin Varacillin, Takacillin美西林Mecillinam Selexidleo, Selexid, Coactin, Amdinocillin, 氮卓脒青霉素哌拉西林钠Piperacillin Sodium 氧哌嗪青霉素, 哔哌西林, 哌氨苄青霉素Avocin, Orocin, Pipril氯唑西林钠Cloxacillin Sodium 邻氯青霉素钠, 氯唑青, Orbenin阿帕西林钠Apalcillin Sodium 萘啶青霉素钠, APPC, Lumota, Elumota, Palcin磺苄西林钠Sulbenicillin Sodium 磺苄青霉素钠, 卡他西林, 格达西林Sulfocillin, Lilacillin, Kedacillin青霉素V钾Phenoxymethylpenicillin Potassiume 6–苯氧乙酰胺基青霉烷酸钾, Cillaphen Distaquaine VK, Compocillin VK, Dowpen VK Cilicaine VK, Apopen, Biopen海他西林钾Hetacillin Potassium 缩酮氨苄青霉素钾, Etacillin, Veisapen卡茚西林钠Carindacillin Sodium Carbenicillin Indanyl Sodium, Geopen, Geocillin 治平霉素替莫西林二钠Temocillin Disodium Temopen头孢菌素类第一代头孢噻吩钠Cefalotin Sodium 先锋Ⅰ号, 头孢金素, 噻孢霉素, CET头孢噻啶Cefaloridine 先锋Ⅱ号, 头孢利素, CER, Kafspor头孢来星Cefaloglycine 先锋Ⅲ号, 头孢甘酸, Kafocin, Kefglycin头孢氨苄Cefalexin 先锋Ⅳ号, 苯甘孢霉素, 头孢力新, CEX头孢唑啉钠Cefazolin Sodium 先锋Ⅴ号, 塞福宁, 西华乐林, 先锋啉, 凯复唑Cefalin, CEX, Cefamedin, Kefzol, Cramaxin头孢拉定Cefradine 先锋Ⅵ号, 头孢雷定, 头孢瑞丁, 头孢环已烯,泛捷复, Velosef, CED, 塞福定头孢乙腈Cefacetrile 先锋Ⅶ号, 头孢腈甲, 头孢赛曲头孢匹林Cefapirin 先锋Ⅷ号, 头孢吡硫, Ceta-Dri头孢硫脒Cefathiamidine 先锋18, 吡脒头孢头孢克洛Cefaclor 赐福乐素, 新达乐, 头孢氯氨苄, Ceclor, 希刻劳,头孢克罗, 可福乐, 氯头孢菌素, CCL头孢羟氨苄Cefadroxil Cefadril, Kefroxil, 羟氨苄头孢菌素, 欧意, CDX,Duracef, Bidocef, Cefamx头孢沙定Cefroxadine 头孢环烯氨, ORASPON, CGP-9000, CXD头孢罗齐Cefprozil 头孢丙烯, Cefzil头孢替唑Ceftezole 特子社复, Tezacef, Alomen第二代头孢呋辛钠Cefuroxime Sodium 头孢呋肟, 赐福乐信, 舒贝洛, 西力欣, 特力欣, 明可欣, CXM, Zinacef, Monacef, Ketocef, Furex Kesiut, Supero头孢替安Cefotiam 噻乙胺唑头孢菌素, 头孢噻乙胺唑, 泛司博林, 泛司颇灵, Pansparin, Halospor, CTM头孢呋辛酯Cefuroxime Axetil 头孢呋肟酯, 新菌灵, 西力达, 头孢呋新乙酰乙酯Zinnat头孢西丁Cefoxitin 头孢氧唑, 甲氧头霉噻吩, 噻吩甲氧头孢菌素, 美福仙, 甲氧头霉噻吩, CXT, CFX头孢尼西二钠Cefonicid Disodium 铭乐希, Monocid, Cefonicid, Cefodie, Cefol头孢孟多Cefamandole 头孢羟唑, 羟苄四唑头孢菌素, Mandolkef, CMT, Cefadole, Mandol头孢美唑钠Cefmetazole Sodium 先锋美他醇, 氰唑甲氧头孢菌素, 头孢氰四唑,头孢美他唑, CEFMETAZON, CMZ, Cemetol头孢布宗Cefbuperazone 头孢拉宗, Keiperazon, Tomiporan, Cefobutazine, CBPZ 头孢雷特Ceforanide 头孢氨甲苯唑, 头孢苄胺四唑, 氨苄唑头孢菌素Precef第三代头孢地尼Cefdinir Cefzon头孢布坦Ceftibuten 头孢布烯, Cedax头孢卡品Cefcapene Pivoxil 头孢卡喷新戊酰氧甲酯, Flomox头孢噻肟钠Cefotaxime Sodium 头孢氨噻肟, 泰可欣, 塞福隆, 菌必灭, 治菌必妥, 凯福隆, 凯复龙, 头孢噻肟, 喜福得, Claforan, CTX头孢曲松钠Ceftriaxone Sodium 头孢三嗪, 头孢泰克松, 罗氏芬, 罗噻嗪, 菌必治, 菌得治, 头孢三嗪噻肟, 泛生舒复, 西华瑞隆, Rocephin, Ro-139904, CTRX 头孢哌酮钠Cefoperazone Sodium 头孢氧哌唑, 先锋必, 头孢必, 达诺欣, 塞福必,Cefobid, T-1551, CPZ头孢他啶Ceftazidime 头孢塔齐定, 头孢羧甲噻肟, 复达欣, 凯复定, Glazidine, Fortaz, Eposerin, Modocin, Fotrum, Tazidime, CTZ, Spectrum, Eposerin, Modocin头孢唑肟Ceftizoxime 头孢去甲噻肟, 益保世灵, 安保速灵, Epocelin CZX, CEFTIZOX头孢克肟Cefixime 头孢烯噻羟肟, 世伏素, 世福素, FK027, Suprax, CFIX , CEFSPAN头孢甲肟Cefmenoxime 头孢氨噻肟唑, 倍司特克, BESTCALL, CMX头孢地嗪Cefodizime 头孢双唑, 莫敌, 莫敌威, Modivid, Timcef头孢匹胺Cefpiramide 先福吡兰, 甲吡唑头孢菌素, 头孢吡胺, CPM,Cefpiran, Sepatren头孢特仑酯Cefteram Pivoxil 头孢特仑新戊酰氧甲酯, 托米仑, 头孢他美酯,富山龙, Tomiron头孢磺吡苄钠Cefsulodin Sodium 头孢磺吡酮, 头孢磺啶钠, 磺吡苄头孢菌素钠,达克舒林, Cefsulodine, Takesulin, CFS, SCE129拉他头孢Latamoxef 羟羧氧酰胺菌素, 拉氧头孢, 头孢拉坦, 噻吗灵Moxalactam, Shiomarin, Moxam, LMOX头孢米诺Cefminox 氨羧甲氧头孢菌素, 美土灵, Meicelin头孢咪唑Cefpimizole Benilan, SPIE, Ajicef头孢替坦二钠Cefotetan Disodium 双硫唑甲氧头孢霉素, Yamatetan, CTT, Cefotan第四代头孢唑喃钠Cefuzonam Sodium Cosmosin, CZON氟氧头孢钠Flomoxef Sodium 氟莫克西, 6315-S头孢匹罗Cefpirome 头孢吡隆, 氨噻肟吡戊头孢其它Β-内酰胺类亚胺培南Imipenem 伊米配能, 亚胺硫霉素, NFT氯曲南Aztreonam 菌克单, 君刻单, 噻肟单酰胺菌素, AZACTAM,Primbactam, Primbactin, SQ-26776氟罗培南Faropenem 福劳派南, Farom苄西林/氯唑西林Ampicillin/Cloxacillin 复方安比西林, 爱罗苏, 氨氯西林, 白罗仙, 淋必清, Pinocine亚胺培南/西司他丁Imipenem/Cilastatin 亚胺硫霉素/西拉司丁, 泰能, TIENAM, PRIMAXIN阿莫西林/氟氯西林Amoxicillin/Flucloxacillin 氟羟西林, 新灭菌, Biflocin, Infectrin三羟阿莫西林/单羟双氯西林Amoxycillin Trihydrate/Dicloxacillin康彼身, 克菌, CompliscanΒ-内酰胺类抗生类+Β-内酰胺酶抑制剂氨苄西林/舒巴坦Ampicillin/Sulbactam 强力安必仙, 舒他西林, 优力新, 新凯兰欣, 舒氨欣, Unasyn, Sultamicillin头孢哌酮/舒巴坦Cefoperazone/Sulbactam 舒普深, 舒哌酮, Sulperazone头孢噻肟/舒巴坦Cefotaxime/Sulbactam 新治菌哌拉西林/他佐巴坦Piperacillin/Tazobactam Tazocin, YP-14阿莫西林/克拉维酸Amoxillin/Clavulanic Acid 安灭菌, 安美汀, 奥格门汀, 安美汀, 阿莫克拉Augmentin, BRL25000替卡西林/克拉维酸Ticarcillin/Clavulanic Acid 泰门汀, 特泯菌, 特美汀, Timentin舒巴坦Sulbactam 舒巴克坦, 陪他美, 青霉烷砜氨基糖甙类链霉素Streptomycin RIMACTANE, RIFAMPINN, ovostrep庆大霉素Gentamycin 庆大霉素C, 瑞贝克, 正泰霉素庆大霉素链Gentamicin Chains 塞透派勒链, Septopal妥布霉素Tobramycin 立可信软膏,点必舒眼药水(妥布+地塞米松)泰星,妥布拉霉素,托普霉素,NEBCIN,Factorb, Brulamycin, Tobra, Nebramycin, Gernebcin, Obracine小诺霉素Micronomicin 小诺米星, 沙加霉素, 相模霉素, Sagamicin, Kw-1062, MCR核糖霉素Ribostamycin 威他霉素, 维生霉素, Vistamycin, Ibistacin大观霉素Spectinomycin 奇霉素, 壮观霉素, 淋必治, 奈毒素, Spectram, 克淋, Trobicin, Kirin阿米卡星Amikacin 丁胺卡那霉素, Amikin, Likacin西索米星Sisomicin 西梭霉素, 西索霉素, 紫苏霉素, Sisomin, Sipeptin奈替米星Netilmicin 乙基西梭霉素, 奈特, 奈替霉素, 乙基西素米星, 立克菌星, 乙基紫苏毒素, Ethylsisomicin, Vectacin, Zetamicn, Certomycin, NETROMYCIN异帕米星Isepamicin 依克沙霉素, HAPA-B, Exacin阿司米星Astromicin 阿司霉素, 福提霉素, 武夷霉素, 强壮霉素FORTIMICIN, Kw-1070, ASTM, Fortimicin地贝卡星Dibekacin 双去氧卡那霉素B, Dideoxykanamycin B, DKB, 达苄霉素, Icacine依替米星Etimicin 悉能磷霉素类磷霉素Fosfomycin 福赐美仙, Phosphonomycin, Fosfocina, FOM磷霉素氨基丁三醇Fosfomycin Tromethamine Monurol喹诺酮类第二代吡哌酸Pipemidic Acid PPA第三代诺氟沙星Nofloxacin 氟哌酸, 淋克星, Fulgram, Noroxin, AM-715 MK-0366, Brazan, Baccidal环丙沙星Ciprofloxacin 悉复欣, 悉普欣, 悉普宁, 丽珠环丙, 特美力,环丙氟哌酸, 健宝灵, CIPRO, Bay-0-9867, Ciprobay, Ciproxin培氟沙星Pefloxacin 培福新, 甲氟哌酸, 倍泰, Peflacine洛美沙星Lomefloxacin 洛威, 罗氟酸, 欣美罗, 多龙, Bareon芦氟沙星Rufloxacin 如氟沙星左旋氧氟沙星Levofloxacin 可乐必妥, 左氟沙星, Cravit依诺沙星Enoxacin 氟啶酸, 福禄马, 复克, FLUMARK, GYRAMID,Flumark氟罗沙星Fleroxacin 复诺定, 多氟哌酸, 喹诺敌, 麦加乐定, 沃尔得FLX, Megelone, Quinodis, Ro-236240, AM-833氧氟沙星Ofloxacin 氟嗪酸, 秦利必妥, 泰利特, 奥复星, 康泰必妥, 竹安新, TARIVID, 赞诺欣, Zanoxin, Oflocin, 泰利得, 正康培氟沙星Pefloxacin 甲氟哌酸, 培氟哌酸, 培福新, 倍宁, Pefalcine。

医药研发常用英语词汇大全

医药研发常用英语词汇大全

医药研发常用英语词汇大全以下是一些医药研发领域常用的英语词汇,这些词汇涵盖了药物研发、临床试验、生物技术等多个方面。

请注意,这只是一个基本的参考,具体领域可能有更专业的术语。

1.Drug Discovery and Development(药物发现与开发):•Drug target: 药物靶点•Lead compound: 引导化合物•High-throughput screening: 高通量筛选•Hit compound: 命中化合物•Medicinal chemistry: 药物化学•Pharmacokinetics: 药代动力学•Pharmacodynamics: 药效动力学•Preclinical studies: 临床前研究2.Clinical Trials(临床试验):•Informed consent:知情同意•Placebo: 安慰剂•Randomized controlled trial (RCT): 随机对照试验•Double-blind study: 双盲研究•Phase I/II/III trials: Ⅰ/Ⅱ/Ⅲ期临床试验•Adverse events: 不良事件•Efficacy: 疗效•Safety: 安全性3.Biotechnology(生物技术):•Recombinant DNA technology: 重组DNA技术•Genetically modified organism (GMO): 转基因生物•Cloning: 克隆•Gene therapy: 基因治疗•Stem cells: 干细胞•Bioprocessing: 生物加工•Bioinformatics: 生物信息学4.Regulatory Affairs(法规事务):•Regulatory submission: 法规提交•Investigational New Drug (IND): 新药申请•New Drug Application (NDA): 新药上市申请•Good Manufacturing Practice (GMP): 良好生产规范•Good Clinical Practice (GCP): 良好临床实践5.Pharmacology(药理学):•Receptor: 受体•Agonist: 激动剂•Antagonist: 拮抗剂•Pharmacogenetics: 药理遗传学•Toxicology: 毒理学6.Quality Control(质量控制):•Batch release: 批释放•Quality assurance: 质量保证•Certificate of Analysis (CoA): 分析证书•Stability testing: 稳定性测试这些词汇只是医药研发领域中的一小部分,具体的词汇会根据不同的子领域而有所不同。

药物临床试验英文词汇及缩写

药物临床试验英文词汇及缩写

药物临床试验英文缩写药物临床试验英文缩写文案大全文案大全文案大全文案大全文案大全文案大全文案大全实验室检查英文缩写文案大全文案大全Accuracy 准确度Active control,AC 阳性对照,活性对照Adverse drug reaction,ADR 药物不良反应Adverse event,AE 不良事件Adverse medical events 不良医学事件Adverse reaction 药物不良反应Alb 白蛋白ALD(Approximate Lethal Dose)近似致死剂量ALP 碱性磷酸酶Alpha spending function 消耗函数ALT 丙氨酸氨基转换酶Analysis sets 统计分析的数据集Approval 批准Assistant investigator 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Audit or inspection 稽查/视察Audit report 稽查报告Auditor 稽查员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Blind review 盲态检查Blinding method 盲法Blinding/ masking 盲法,设盲Block 分段Block 层Block size 每段的长度BUN 尿素氮Carryover effect 延滞效应Case history 病历Case report form 病例报告表Case report form/ case record form,CRF 病例报告表,病例记录表Categorical variable 分类变量Cav 平均浓度CD 圆二色谱CL 清除率Clinical equivalence 临床等效应Clinical study 临床研究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Clinical trial protocol,CTP 临床试验方案Clinical trial/ study report 临床试验报告Cmax 峰浓度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Confidence interval 可信区间Confidence level 置信水平Consistency test 一致性检验Contract research organization,CRO 合同研究组织Contract/ agreement 协议/合同Control group 对照组Coordinating committee 协调委员会Crea 肌酐CRF(case report form)病例报告表Crossover design 交叉设计Cross-over study 交叉研究Css 稳浓度Cure 痊愈Data management 数据管理Database 建立数据库Descriptive statistical analysis 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-reaction relation 剂量-反应关系Double blinding 双盲Double dummy 双模拟Double dummy technique 双盲双模拟技术Double-blinding 双盲Drop out 脱落DSC 差示扫描热量计Effectiveness 疗效Electronic data capture,EDC 电子数据采集系统Electronic data processing,EDP 电子数据处理系统Emergency envelope 应急信件End point 终点Endpoint criteria/ measurement 终点指标Equivalence 等效性Essential documentation 必须文件Ethics committee 伦理委员会Excellent 显效Exclusion criteria 排除标准Factorial design 析因设计Failure 无效,失败Final point 终点Fixed-dose procedure 固定剂量法Forced titration 强制滴定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Global assessment variable 全局评价变量GLU 血糖Good clinical practice,GCP 药物临床试验质量管理规范Good manufacture practice,GMP 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Group sequential design 成组序贯设计Health economic evaluation,HEV 健康经济学评价Hypothesis test 假设检验Hypothesis testing 假设检验International Conference of Harmonization,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Inclusion criteria 入选标准Independent ethics committee,IEC 独立伦理委员会Information consent form,ICF 知情同意书Information gathering 信息收集Informed consent,IC 知情同意Initial meeting 启动会议Inspection 视察/检查Institution inspection 机构检查Institution review board,IBR 机构审查委员会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Investigator 研究者Investigator's brochure,IB 研究者手册IR 红外吸收光谱Ka 吸收速率常Last observation carry forward,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Logic check 逻辑检查LOQ (Limit of Quantitation)定量限LOCF,Last observation carry forward 最近一次观察的结转Lost of follow up 失访Marketing approval/ authorization 上市许可证Matched pair 匹配配对Missing value 缺失值Mixed effect model 混合效应模式Monitor 监查员Monitoring 监查Monitoring report 监查报告MRT 平均滞留时间MS 质谱MS-MS 质谱-质谱联用MTD(Maximum Tolerated Dose)最大耐受剂量Multicenter trial 多中心试验Multi-center trial 多中心试验New chemical entity,NCE 新化学实体New drug application,NDA 新药申请NMR 核磁共振谱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ODR 旋光光谱Open-blinding 非盲Open-label 非盲Optional titration 随意滴定Original medical record 原始医疗记录Outcome 结果Outcome assessment 结果指标评价Outcome measurement 结果指标Outlier 离群值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Primary endpoint 主要终点Primary variable 主要变量Principal investigator 主要研究者Principle investigator,PI 主要研究者Product license,PL 产品许可证Protocol 试验方案Protocol 试验方案Protocol amendment 方案补正Quality assurance unit,QAU 质量保证部门Quality assurance,QA 质量保证Quality control,QC 质量控制Query list,query form 应用疑问表Randomization 随机化Randomization 随机Range check 范围检查Rating scale 量表Regulatory authorities,RA 监督管理部门Replication 可重复RSD 日内和日间相对标准差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 样本含量Sample size 样本量,样本大小Scale of ordered categorical ratings 有序分类指标Secondary variable 次要变量Sequence 试验次序Serious adverse event,SAE 严重不良事件Serious adverse reaction,SAR 严重不良反应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Single-blinding 单盲Site audit 试验机构稽查SOP 试验室的标准操作规程Source data verification,SDV 原始数据核准Source data,SD 原始数据Source document,SD 原始文件Specificity 特异性Sponsor 申办者Sponsor-investigator 申办研究者Standard curve 标准曲线Standard operating procedure,SOP 标准操作规程Statistic 统计量Statistical analysis plan 统计分析计划Statistical analysis plan 统计参数计划书Statistical analysis plan,SAP 统计分析计划Statistical model 统计模型Statistical tables 统计分析表Stratified 分层Study audit 研究稽查Subgroup 亚组Sub-investigator 助理研究者Subject 受试者Subject diary 受试者日记Subject enrollment 受试者入选Subject enrollment log 受试者入选表Subject identification code,SIC 受试者识别代码Subject recruitment 受试者招募Subject screening log 受试者筛选表Superiority 检验Survival analysis 生存分析SXRD 单晶X-射线衍射System audit 系统稽查T1/2 消除半衰期Target variable 目标变量T-BIL 总胆红素T-CHO 总胆固醇TG 热重分析TLC、HPLC 制备色谱Tmax 峰时间TP 总蛋白Transformation 变量变换Treatment group 试验组Trial error 试验误差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Unblinding 揭盲Unblinding 破盲Unexpected adverse event,UAE 预料外不良事件UV-VIS 紫外-可见吸收光谱Variability 变异Variable 变量Visual analogy scale 直观类比打分法Visual check 人工检查Vulnerable subject 弱势受试者Wash-out 清洗期Washout period 洗脱期Well-being 福利,健康1.临床试验(Clinical Trial):指任何在人体(病人或健康志愿者身上)进行药品的系统性研究,以证实或揭示研究药品的作用、不良反应及/或试验用药品的吸收、分布、代谢和排泄,目的是确定研究药品的疗效与安全性。

临床试验相关英文及缩写

临床试验相关英文及缩写

22 Blood Biochemistry 血液生化
23 Blank Control 空白对照 [blæŋk] [kən 'trəʊl] chuou
23 Calcium 钙
24 Blinding/Masking 盲法/设盲
24 Magnesium 镁
25 Randomized, Double-blind Study 随机对照双盲试验
不良反应相关 1 ADR- Adverse Drug Reaction 药物不良反应 2 AE- Adverse Event 不良事件 3 SAE Serious Adverse Event 严重不良事件 4 Seriousness 严重性(性质) 5 Severity 严重程度(程度) 6 Grade 级别 7 Results in death 导致死亡 8 Life threatening 危急生命 9 Requires or prolongs hospitalization 导致或延长住院时间
35 ALP-Alkaline Phosphatase 碱性磷酸酶 36 TB- Total Bilirubin 总胆红素 37 LDH 乳酸脱氢酶 38 GGT 谷氨酰转氨酶 39 Glucose 葡萄糖 40 Blood Coagulation 凝血 41 PT-Prothrombin Time 凝血酶原时间 42 PT-INR 凝血酶原时间-国际标准化比值 43 APTT 活化部分凝血活酶时间
6 Study Design 研究设计 [dɪ'zaɪn]
6 RBC-Red Blood Cell 红细胞
7 Study Procedure 研究流程
7 WBC-White Blood Cell 白细胞
8 Study Completion 研究完成 [kəm 'pli ʃən]

临床试验常用英文术语

临床试验常用英文术语

临床试验常用英文术语Clinical Trial Common English TerminologyThe field of clinical trials is a crucial aspect of medical research and drug development. It involves the systematic evaluation of new treatments, medications, or interventions to assess their safety, efficacy, and potential benefits for patients. Throughout this process, researchers and medical professionals utilize a wide array of specialized terminology, most of which is in English. Understanding these common English terms is essential for effective communication and collaboration in the context of clinical trials.One of the fundamental concepts in clinical trials is the "study protocol," which outlines the detailed plan for conducting the trial. This document includes the objectives, study design, participant selection criteria, treatment regimens, and the methods for data collection and analysis. A crucial component of the protocol is the "informed consent" process, which ensures that study participants are fully aware of the risks, benefits, and their rights before agreeing to take part in the trial.Another important term is the "study population," which refers to thegroup of individuals who meet the eligibility criteria and are selected to participate in the trial. These individuals are often referred to as "study subjects" or "study participants." The selection of the study population is a crucial step, as it ensures that the results of the trial are representative of the target patient population.The "study design" is the overall framework that guides the conduct of the clinical trial. There are various study designs, such as randomized controlled trials, observational studies, and crossover studies, each with its own strengths and limitations. The "randomization" process, where participants are randomly assigned to different treatment groups, is a key aspect of many clinical trial designs, as it helps to minimize bias and ensure the validity of the results.The term "blinding" is also widely used in clinical trials. It refers to the practice of keeping certain information about the study, such as the treatment assignment, hidden from the participants, researchers, or both. This helps to reduce the impact of personal biases and preconceptions on the evaluation of the study outcomes.During the course of a clinical trial, researchers collect a significant amount of data, which is referred to as the "study data." This data includes information about the participants' demographics, medical history, treatment adherence, adverse events, and clinical outcomes.The "data collection" process often involves the use of case report forms (CRFs), which are standardized documents used to record the study data.The analysis of the study data is a critical step in the clinical trial process. Researchers use various "statistical methods" to evaluate the safety and efficacy of the intervention being studied. These methods may include hypothesis testing, regression analysis, and the calculation of "p-values" to determine the statistical significance of the results.Another important term in clinical trials is the "adverse event," which refers to any undesirable medical occurrence that happens to a study participant, regardless of whether it is directly related to the intervention being tested. The identification, reporting, and management of adverse events are crucial for ensuring the safety of the participants and the overall integrity of the trial.The "regulatory agencies," such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), play a crucial role in the clinical trial process. These agencies are responsible for reviewing and approving the study protocols, monitoring the conduct of the trials, and ultimately deciding whether to approve new drugs or medical interventions for clinical use.Finally, the term "clinical trial phase" is used to describe the different stages of the drug development process. There are typically four phases of clinical trials, with each phase having its own objectives and requirements. The successful completion of all four phases is generally required for a new drug or intervention to be approved for commercial use.In conclusion, the understanding of common English terminology used in clinical trials is essential for researchers, healthcare professionals, and individuals involved in the development and evaluation of new treatments. Mastering these terms not only facilitates effective communication but also ensures the proper conduct and interpretation of clinical research, ultimately leading to improved patient care and outcomes.。

临床试验常用中英文词汇【精品】

临床试验常用中英文词汇【精品】

SFDA Glossary:GCP,GLP,TRIAL Accuracy 准确度Active control,AC 阳性对照,活性对照Adverse drug reaction,ADR 药物不良反应Adverse event,AE 不良事件Adverse medical events 不良医学事件Adverse reaction 药物不良反应Alb 白蛋白ALD(Approximate Lethal Dose)近似致死剂量ALP 碱性磷酸酶Alpha spending function 消耗函数ALT 丙氨酸氨基转换酶Analysis sets 统计分析的数据集Approval 批准Assistant investigator 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Audit or inspection 稽查/视察Audit report 稽查报告Auditor 稽查员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Blind review 盲态检查Blinding method 盲法Blinding/ masking 盲法,设盲Block 分段Block 层Block size 每段的长度BUN 尿素氮Carryover effect 延滞效应Case history 病历Case report form 病例报告表Case report form/ case record form,CRF 病例报告表,病例记录表Categorical variable 分类变量Cav 平均浓度CD 圆二色谱CL 清除率Clinical equivalence 临床等效应Clinical study 临床研究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Clinical trial protocol,CTP 临床试验方案Clinical trial/ study report 临床试验报告Cmax 峰浓度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Confidence interval 可信区间Confidence level 置信水平Consistency test 一致性检验Contract research organization,CRO 合同研究组织Contract/ agreement 协议/合同Control group 对照组Coordinating committee 协调委员会Crea 肌酐CRF(case report form)病例报告表Crossover design 交叉设计Cross-over study 交叉研究Css 稳浓度Cure 痊愈Data management 数据管理Database 建立数据库Descriptive statistical analysis 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-reaction relation 剂量-反应关系Double blinding 双盲Double dummy 双模拟Double dummy technique 双盲双模拟技术Double-blinding 双盲Drop out 脱落DSC 差示扫描热量计Effectiveness 疗效Electronic data capture,EDC 电子数据采集系统Electronic data processing,EDP 电子数据处理系统Emergency envelope 应急信件End point 终点Endpoint criteria/ measurement 终点指标Equivalence 等效性Essential documentation 必须文件Ethics committee 伦理委员会Excellent 显效Exclusion criteria 排除标准Factorial design 析因设计Failure 无效,失败Final point 终点Fixed-dose procedure 固定剂量法Forced titration 强制滴定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Global assessment variable 全局评价变量GLU 血糖Good clinical practice,GCP 药物临床试验质量管理规范Good manufacture practice,GMP 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Group sequential design 成组序贯设计Health economic evaluation,HEV 健康经济学评价Hypothesis test 假设检验Hypothesis testing 假设检验International Conference of Harmonization,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Inclusion criteria 入选标准Independent ethics committee,IEC 独立伦理委员会Information consent form,ICF 知情同意书Information gathering 信息收集Informed consent,IC 知情同意Initial meeting 启动会议Inspection 视察/检查Institution inspection 机构检查Institution review board,IBR 机构审查委员会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Investigator 研究者Investigator's brochure,IB 研究者手册IR 红外吸收光谱Ka 吸收速率常Last observation carry forward,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Logic check 逻辑检查LOQ (Limit of Quantitation)定量限LOCF,Last observation carry forward 最近一次观察的结转Lost of follow up 失访Marketing approval/ authorization 上市许可证Matched pair 匹配配对Missing value 缺失值Mixed effect model 混合效应模式Monitor 监查员Monitoring 监查Monitoring report 监查报告MRT 平均滞留时间MS 质谱MS-MS 质谱-质谱联用MTD(Maximum Tolerated Dose)最大耐受剂量Multicenter trial 多中心试验Multi-center trial 多中心试验New chemical entity,NCE 新化学实体New drug application,NDA 新药申请NMR 核磁共振谱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ODR 旋光光谱Open-blinding 非盲Open-label 非盲Optional titration 随意滴定Original medical record 原始医疗记录Outcome 结果Outcome assessment 结果指标评价Outcome measurement 结果指标Outlier 离群值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Primary endpoint 主要终点Primary variable 主要变量Principal investigator 主要研究者Principle investigator,PI 主要研究者Product license,PL 产品许可证Protocol 试验方案Protocol 试验方案Protocol amendment 方案补正Quality assurance unit,QAU 质量保证部门Quality assurance,QA 质量保证Quality control,QC 质量控制Query list,query form 应用疑问表Randomization 随机化Randomization 随机Range check 范围检查Rating scale 量表Regulatory authorities,RA 监督管理部门Replication 可重复RSD 日内和日间相对标准差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 样本含量Sample size 样本量,样本大小Scale of ordered categorical ratings 有序分类指标Secondary variable 次要变量Sequence 试验次序Serious adverse event,SAE 严重不良事件Serious adverse reaction,SAR 严重不良反应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Single-blinding 单盲Site audit 试验机构稽查SOP 试验室的标准操作规程Source data verification,SDV 原始数据核准Source data,SD 原始数据Source document,SD 原始文件Specificity 特异性Sponsor 申办者Sponsor-investigator 申办研究者Standard curve 标准曲线Standard operating procedure,SOP 标准操作规程Statistic 统计量Statistical analysis plan 统计分析计划Statistical analysis plan 统计参数计划书Statistical analysis plan,SAP 统计分析计划Statistical model 统计模型Statistical tables 统计分析表Stratified 分层Study audit 研究稽查Subgroup 亚组Sub-investigator 助理研究者Subject 受试者Subject diary 受试者日记Subject enrollment 受试者入选Subject enrollment log 受试者入选表Subject identification code,SIC 受试者识别代码Subject recruitment 受试者招募Subject screening log 受试者筛选表Superiority 检验Survival analysis 生存分析SXRD 单晶X-射线衍射System audit 系统稽查T1/2 消除半衰期Target variable 目标变量T-BIL 总胆红素T-CHO 总胆固醇TG 热重分析TLC、HPLC 制备色谱Tmax 峰时间TP 总蛋白Transformation 变量变换Treatment group 试验组Trial error 试验误差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Unblinding 揭盲Unblinding 破盲Unexpected adverse event,UAE 预料外不良事件UV-VIS 紫外-可见吸收光谱Variability 变异Variable 变量Visual analogy scale 直观类比打分法Visual check 人工检查Vulnerable subject 弱势受试者Wash-out 清洗期Washout period 洗脱期Well-being 福利,健康。

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临床试验常用英语词汇大全基础词汇Clinical Trial临床试验Protocol试验方案Synopsis摘要Study Objective研究目的Study Endpoint研究终点Study Design研究设计Study Procedure研究流程Study Completion研究完成Study Termination研究终止Baseline基线Inclusion Criteria入组标准Exclusion Criteria排除标准IVRS- Interactive Voice Response System交互式语音应答系统IWRS- Interactive Web Response System交互式网络应答系统SDV -Source Data Verification原始数据核查EDC- Electronic Data Capture电子数据采集Statistical Methods统计学方法Single Blinding单盲Double Blinding双盲Placebo安慰剂Placebo Control安慰剂对照Active Control阳性对照、活性对照Blank Control空白对照Blinding/Masking盲法/设盲Randomized, Double-blind Study随机对照双盲试验Outcome Assessment结果评价Multi-center Trial多中心试验OS-Overall Survival总生存期PFS- Progression Free Survival无进展生存期Contract/Agreement合同/ 协议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SOP- Standard Operating Procedure标准操作规程Protocol Amendments修正案CRF- Case Report Form病历报告表IB- Investigator’ s Brochure研究者手册ICF- Informed Consent Form知情同意书QA- Quality Assurance质量保证QC-Quality Control质量控制Monitoring监查Monitor监查员Audit稽查Auditor稽查员Inspection视察CFDA - China Food and Drug Administration国家食品药品监督管理局FDA- Food and Drug Administration美国食品与药品监督管理局ICH- International Conference on Harmonization国际协调会议IEC Independent Ethics Committee独立伦理委员会IRB-Institutional Review Board机构审查委员会Sponsor申办者CRO -Contract Research Organization合同研究组织SMO-Site Management Organization现场管理组织Investigational Site研究中心Investigator研究者PI- Principal Investigator主要研究者SI- Sub-investigator助理研究者CRC- Clinical Research Coordinator临床研究协调员Initial Meeting启动会SIV-Site Initiation Visit中心启动访视受试者相关Subject受试者Subject Screening Log受试者筛选表Subject Enrollment Log受试者入选表Subject Identification Code受试者识别代码FPI/FSI-First Patient/Subject In首例受试者入组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Recruitment招募Screening筛选Randomization随机Enrollment入组Visit访视Visit Window访视窗口期Out of Visit Window超窗Follow Up随访Withdrawal脱落Compliance依从性Wash-out Period洗脱期Cycle周期Treatment Allocation治疗分配Patient File病人档案Case Record/Medical History病历SD -Source Data/Document/Documentation原始数据/文件Subject Diary受试者日记Demography人口统计学DOB-Date of Birth出生日期Race种族Physical Exam体格检查Vital Signs生命体征Height身高Weigh体重Temperature体温Pulse/Heart rate脉搏/心率Systolic Blood Pressure收缩压Diastolic Blood Pressure舒张压ECG-Electrocardiogram心电图Chest X-ray胸部X光Image影像学实验室相关Laboratory Assessment实验室评估CS/NCS-Clinical Significant/Non-Clinical Significant有临床意义/无临床意义Hematology/Blood Routine Test血液学/血常规Hemoglobin血红蛋白Platelets血小板RBC-Red Blood Cell红细胞WBC-White Blood Cell白细胞Neutrophils中性粒细胞Lymphocytes淋巴细胞Monocytes单核细胞Eosinophils嗜酸性粒细胞Basophils嗜碱性粒细胞Urinalysis尿液分析Glucose葡萄糖Ketones酮体Leukocytes粒性白细胞Nitrite亚硝酸盐Bilirubin胆红素Protein蛋白Crystals晶体pH酸碱度Blood Biochemistry血液生化Calcium钙Magnesium镁Phosphorus磷Sodium钠Potassium钾Chloride氯Creatinine肌酐BUN-Blood Urea Nitrogen尿素氮TP- Total Protein总蛋白Albumin白蛋白AST /SGOT谷草转氨酶/ 门冬氨酸氨基转移酶ALT/ SGPT谷丙转氨酶/ 丙氨酸氨基转移酶ALP-Alkaline Phosphatase碱性磷酸酶TB- Total Bilirubin总胆红素LDH乳酸脱氢酶GGT谷氨酰转氨酶Glucose葡萄糖Blood Coagulation凝血PT-Prothrombin Time凝血酶原时间PT-INR凝血酶原时间- 国际标准化比值APTT活化部分凝血活酶时间药物相关IP-Investigational Product研究产品CM -Concomitant Medication合并用药Drug Receive药物接收Drug Storage药物储存Drug Dispense药物分发Drug Return药物返还Drug Destroy药物销毁Quantity数量Medication No.研究药品编号Packaging包装Labeling标签Drug Accountability药物清点Drug Administration药物使用Overdose药物过量Dose Reduce剂量降低Dose Interrupt剂量中断(暂停)Dose Discontinuation剂量终止(完全终止)不良事件相关ADR- Adverse Drug Reaction药物不良反应AE- Adverse Event不良事件SAE Serious Adverse Event严重不良事件Seriousness严重性(性质)Severity严重程度(程度)Grade级别Results in death导致死亡Life threatening危急生命Requires or prolongs hospitalization导致或延长住院时间Congenital anomaly/Birth defect先天畸形 / 出生缺陷Persistent or significant disability/ incapacity永久或重大伤残/ 丧失工作能力Mild轻度Moderate中度Severe重度Safety Assessment/Evaluation安全评估SUSAR=Serious and Unexpected Suspected Adverse Reaction严重的非预期疑似相关的药品不良反应Anemia贫血(血红蛋白降低)Hemoglobin increased血红蛋白升高Hypertension高血压Hypotension低血压Abdominal pain腹痛Stomach pain胃痛Constipation便秘Diarrhea腹泻Nausea恶心Vomiting呕吐Cough咳嗽Fatigue疲劳Fever发热Pain疼痛Anorexia厌食症(食欲不振)Headache头痛Hypersomnia嗜睡Insomnia失眠Alopecia脱发Weight gain体重增加Weight loss体重降低Clinical summary report CSR临床总结报告Statistical analysis report SAR统计分析报告。

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