醫(yī)藥常用英語單詞及縮寫

1、精選文檔FDA（food and drug adminisration）：（美國）食品藥品監(jiān)督管理局NDA（new drug application）：新藥申請ANDA（abbreviated new drug application）：簡化新藥申請EP（export application）：出口藥申請（申請出口不被批準(zhǔn)在美國銷售的藥品）treatment IND：研究中的新藥用于治療abbreviated（new）drug：簡化申請的新藥DMF（drug master file）：藥物主文件（持有者為謹(jǐn)慎起見而準(zhǔn)備的保密資料，可以包括一個或多個人用藥物在制備、加工、包裝和貯存過程中所涉及的

2、設(shè)備、生產(chǎn)過程或物品。只有在DMF持有者或授權(quán)代表以授權(quán)書的形式授權(quán)給FDA，F(xiàn)DA在審查IND、NDA、ANDA時才能參考其內(nèi)容）holder：DMF持有者CFR（code of federal regulation）：（美國）聯(lián)邦法規(guī)PANEL：專家小組batch production：批量生產(chǎn)；分批生產(chǎn)batch production records：生產(chǎn)批號記錄post or pre-market surveillance：銷售前或銷售后監(jiān)督informed consent：知情同意（患者對治療或受試者對醫(yī)療試驗了解后表示同意接受治療或試驗）prescription drug：處方藥O

3、TC drug（overthecounter drug）：非處方藥U.S. public health service：美國衛(wèi)生福利部NIH（national institute of health）：（美國）全國衛(wèi)生研究所animal trail：動物試驗accelerated approval：加速批準(zhǔn)standard drug：標(biāo)準(zhǔn)藥物investigator ：研究人員；調(diào)研人員preparing and submitting：起草和申報submission：申報；遞交benefit(s)：受益risk（s）：受害drug product：藥物產(chǎn)品drug substance：原料藥e

4、stablished name：確定的名稱generic name：非專利名稱proprietary name：專有名稱；INN（international nonproprietary name）：國際非專有名稱narrative summary: 記敘體概要adverse effect：副作用adverse reaction：不良反應(yīng)protocol：方案archival copy：存檔用副本review copy：審查用副本official compendium：法定藥典（主要指USP、 NF）USP（the united state pharmacopeia）：美國藥典（現(xiàn)已和NF合并

5、一起出版）NF（national formulary）：（美國）國家藥品集officialpharmacopeial = compendial：藥典的；法定的；官方的agency：審理部門（指FDA）sponsor：主辦者（指負(fù)責(zé)并著手臨床研究者）identity：真?zhèn)危昏b別；特性strength：規(guī)格；規(guī)格含量（每一劑量單位所含有效成分的量）labeled amount：標(biāo)示量regulatory specification：質(zhì)量管理規(guī)格標(biāo)準(zhǔn)（NDA提供）regulatory methodology：質(zhì)量管理方法（FDA用于考核原料藥或藥物產(chǎn)品是否符合批準(zhǔn)了的質(zhì)量管理規(guī)格標(biāo)準(zhǔn)的整套步驟）re

6、gulatory methods validation：管理用分析方法的驗證（FDA對NDA提供的方法進(jìn)行驗證）Dietary supplement：食用補(bǔ)充品ICH（International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)人用藥物注冊技術(shù)要求國際協(xié)調(diào)會議ICH：Quality-質(zhì)量Q1A(R2): Stability Testing of New Drug Substances and Products (Seco

7、ndRevision)新原料藥和制劑的穩(wěn)定性試驗（第二版）Q1B: Photostability Testing of New Drug Substances and Products新原料藥和制劑的光穩(wěn)定性試驗Q1C: Stability Testing for New Dosage Forms新制劑的穩(wěn)定性試驗Q1D: Bracketing and Matrixing Designs for Stability Testing of DrugSubstances and Drug Products原料藥和制劑穩(wěn)定性試驗的交叉和矩陣設(shè)計Q1E: Evaluation of Stability

8、 Data對穩(wěn)定性數(shù)據(jù)的評估處理Q1F: Stability Data Package for Registration Applications in ClimaticZones III and IV在氣候帶III和IV，藥物注冊申請所提供的穩(wěn)定性數(shù)據(jù)Q2A: Text on Validation of Analytical Procedures分析程序的驗證Q2B: Validation of Analytical Procedures: Methodology分析程序的驗證：方法學(xué)Q3A(R): Impurities in New Drug Substances (Revised Gui

9、deline)新原料藥中的雜質(zhì)（修訂版）Q3B(R): Impurities in New Drug Products (Revised Guideline)新制劑中的雜質(zhì)（修訂版）Q3C: Impurities: Guideline for Residual Solvents雜質(zhì)：殘留溶劑指南Q3C(M): Impurities: Guideline for Residual Solvents (Maintenance)雜質(zhì)：殘留溶劑指南（修改內(nèi)容）Q4: Pharmacopoeias藥典Q4A: Pharmacopoeial Harmonisation 藥典的協(xié)調(diào)Q4B: Regulato

10、ry Acceptance of Pharmacopoeial Interchangeability藥典互替在法規(guī)上的可接受性Q5A: Viral Safety Evaluation of Biotechnology Products Derived from CellLines of Human or Animal Origin來源于人或者動物細(xì)胞系的生物技術(shù)產(chǎn)品的病毒安全性評估Q5B: Quality of Biotechnological Products: Analysis of the ExpressionConstruct in Cells Used for Production

11、of r-DNA Derived Protein Products生物技術(shù)產(chǎn)品的質(zhì)量：源于重組DNA的蛋白質(zhì)產(chǎn)品的生產(chǎn)中所用的細(xì)胞中的表達(dá)構(gòu)建分析Q5C: Quality of Biotechnological Products: Stability Testing ofBiotechnological/Biological Products生物技術(shù)產(chǎn)品的質(zhì)量：生物技術(shù)/生物產(chǎn)品的穩(wěn)定性試驗Q5D: Derivation and Characterisation of Cell Substrates Used forProduction of Biotechnological/Biologic

12、al Products用于生產(chǎn)生物技術(shù)/生物產(chǎn)品的細(xì)胞底物的起源和特征描述Q5E: Comparability of Biotechnological/Biological Products Subject toChanges in Their Manufacturing Process基于不同生產(chǎn)工藝的生物技術(shù)產(chǎn)品/生物產(chǎn)品的可比較性Q6: Specifications for New Drug Substances and Products新原料藥和制劑的質(zhì)量規(guī)格Q6A: Specifications: Test Procedures and Acceptance Criteria for

13、 New DrugSubstances and New Drug Products: Chemical Substances質(zhì)量規(guī)格：新原料藥和新制劑的檢驗程序和可接收標(biāo)準(zhǔn)：化學(xué)物質(zhì)Q6B: Specifications: Test Procedures and Acceptance Criteria forBiotechnological/Biological Products質(zhì)量規(guī)格：生物技術(shù)/生物產(chǎn)品的檢驗程序和可接收標(biāo)準(zhǔn)Q7: Good Manufacturing Practices for Pharmaceutical Ingredients活性藥物成份的GMPQ7A: Good M

14、anufacturing Practice Guide for Active PharmaceuticalIngredients活性藥物成份的GMP指南Q8: Pharmaceutical Development藥物研發(fā)Q9: Quality Risk Management質(zhì)量風(fēng)險管理ICH：Safety-安全S1A: Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals藥物致癌性研究需要的指南S1B: Testing for Carcinogenicity of Pharmaceuticals藥物致癌性的檢驗

15、S1C: Dose Selection for Carcinogenicity Studies of Pharmaceuticals藥物致癌性研究之劑量選擇S1C(R): Addendum: Addition of a Limit Dose and Related Notes附錄：極限劑量和有關(guān)注釋的的補(bǔ)充S2A: Guidance on Specific Aspects of Regulatory Genotoxicity Tests forPharmaceuticals受法規(guī)管轄的藥物基因毒性檢驗的特定方面的指南S2B: Genotoxicity: A Standard Battery f

16、or Genotoxicity Testing forPharmaceuticals基因毒性：藥物基因毒性檢驗的標(biāo)準(zhǔn)S3A: Note for Guidance on Toxicokinetics: The Assessment of SystemicExposure in Toxicity Studies毒物代謝動力學(xué)指南的注釋：毒性研究中的全身性暴露量的評估S3B: Pharmacokinetics: Guidance for Repeated Dose Tissue DistributionStudies藥物代謝動力學(xué)：重復(fù)劑量的組織分布研究指南S4: Single Dose Toxic

17、ity Tests單劑量毒性檢驗S4A: Duration of Chronic Toxicity Testing in Animals (Rodent andNon-Rodent Toxicity Testing)動物體內(nèi)慢性毒性持續(xù)時間的檢驗（嚙齒動物和非嚙齒動物毒性檢驗）S5A: Detection of Toxicity to Reproduction for Medicinal Products藥物對生殖發(fā)育的毒性的檢驗S5B(M): Maintenance of the ICH Guideline on Toxicity to Male Fertility: An Addendum

18、 to the Guideline on Detection of Toxicity to Reproduction forMedicinal Products對男性生殖能力的毒性的指南的變動：藥物對生殖發(fā)育的毒性的檢驗指南增加了一個附錄S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals生物技術(shù)生產(chǎn)的藥物的臨床前安全評價S7A: Safety Pharmacology Studies for Human Pharmaceuticals人用藥的安全藥理學(xué)研究S7B: The Nonclinical

19、Evaluation of the Potential for Delayed VentricularRepolarization(QT Interval Prolongation) By Human Pharmaceuticals藥物延遲心室復(fù)極化（QT間期）潛在作用的非臨床評價S8: Immunotoxicology Studies for Human Pharmaceuticals人用藥免疫毒理學(xué)研究M3(M): Maintenance of the ICH Guideline on Non-Clinical Safety Studies forthe Conduct of Human

20、Clinical Trials for Pharmaceuticals藥物的對人臨床試驗的非臨床安全研究指南的變動E-Efficacy（有效）E1: The Extent of Population Exposure to Assess Clinical Safety for DrugsIntended for Long-Term Treatment of Non-Life-Threatening Conditions對用于無生命危險情況下長期治療的藥物進(jìn)行臨床安全評估的族群暴露量范圍E2A: Clinical Safety Data Management: Definitions and S

21、tandards forExpedited Reporting臨床安全數(shù)據(jù)管理：速報制度的定義和標(biāo)準(zhǔn)E2B(R): Revision of the E2B(M) ICH Guideline on Clinical Safety DataManagement Data Elements for Transmission of Individual Case SafetyReports個案安全報告送交的臨床安全數(shù)據(jù)管理的數(shù)據(jù)要素指南（E2B（M）的修訂版E2B (M): Maintenance of the Clinical Safety Data Management including:Dat

22、a Elements for Transmission of Individual Case Safety Reports臨床安全數(shù)據(jù)管理的變動包括：個案安全報告送交的數(shù)據(jù)要素E2B(M): Maintenance of the Clinical Safety Data Management includingQuestions and Answers臨床安全數(shù)據(jù)管理的變動，包括問答E2C: Clinical Safety Data Management: Periodic Safety Update Reports forMarketed Drugs臨床安全數(shù)據(jù)管理：已上市藥品的周期性安全數(shù)

23、據(jù)更新報告Addendum to E2C: Periodic Safety Update Reports for Marketed DrugsE2C的附錄：已上市藥品的周期性安全數(shù)據(jù)更新報告E2D: Post-Approval Safety Data Management: Definitions and Standards forExpedited Reporting批準(zhǔn)后的安全數(shù)據(jù)管理：速報制度的定義和標(biāo)準(zhǔn)E2E: Pharmacovigilance Planning藥物警戒計劃E3: Structure and Content of Clinical Study Reports臨床研究報

24、告的結(jié)構(gòu)和內(nèi)容E4: Dose-Response Information to Support Drug Registration支持藥品注冊的劑量效應(yīng)資料E5: Ethnic Factors in the Acceptability of Foreign Clinical Data引入海外臨床數(shù)據(jù)時要考慮的人種因素E6: Good Clinical Practice: Consolidated GuidelineGCP：良好的臨床規(guī)范：統(tǒng)一的指南E7: Studies in Support of Special Populations: Geriatrics對特定族群的支持的研究：老人病學(xué)E

25、8: General Considerations for Clinical Trials對臨床試驗的總的考慮E9: Statistical Principles for Clinical Trials臨床試驗的統(tǒng)計原則E10: Choice of Control Group and Related Issues in Clinical Trials臨床試驗中控制組和有關(guān)課題的選擇E11: Clinical Investigation of Medicinal Products in the PediatricPopulation小兒科藥物的臨床調(diào)查E12A: Principles for C

26、linical Evaluation of New Antihypertensive Drugs新抗高血壓藥物的臨床評價原則E14: The Clinical Evaluation of QT/QTc Interval Prolongation andProarrhythmic Potential for Non-Antiarrhythmic Drugs非抗心率失常藥物的QT/QTc 間期和致心率失常潛在作用的臨床評價Multidisciplinary Guidelines 多學(xué)科兼容的指南M1: Medical Terminology醫(yī)學(xué)術(shù)語M2: Electronic Standards

27、for Transmission of Regulatory Information(ESTRI)藥政信息傳遞之電子標(biāo)準(zhǔn)M3: Timing of Pre-clinical Studies in Relation to Clinical Trials (SeeSafety Topics)有關(guān)臨床試驗的臨床前研究的時間安排M4: The Common Technical Document (See CTD section for complete Status ofthe guidelines)通用技術(shù)文件（見有關(guān)CTD章節(jié)）M5: Data Elements and Standards for

28、 Drug Dictionaries藥物詞典的數(shù)據(jù)要素和標(biāo)準(zhǔn)臨床試驗常用的英文縮略語TTP： time-to-progression 疾病進(jìn)展時間SAE： severity Adverse Event 嚴(yán)重不良事件AE： Adverse Event 不良事件SOP： Standard Operating Procedure 標(biāo)準(zhǔn)操作規(guī)程CRF： Case Report form 病例報告表DLT： 劑量限制毒性MTD： 最大耐受劑量KPS： Karnofsky Performance Status行為狀態(tài)評分CR： complete response完全緩解PR： partial response部分緩解SD： 病情穩(wěn)定PD： progressive disease病情進(jìn)展CTC： 常用藥物毒性標(biāo)準(zhǔn)IEC： independent ethics committee 獨(dú)立倫理委員會IRB ：