國際藥物注冊英語詞匯

1、精品文檔國際藥物注冊英語詞匯互譯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

2、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設(shè)備、生產(chǎn)過程或物品。只有在DMF寺有者或授權(quán)代表以授權(quán)書的形式授權(quán)給FDA FDAft審查IND、NDA ANDA寸才能參考其內(nèi)容)holder : DMF#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

3、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OTC drug ( over the counter 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

4、報；遞交benefit(s)：受益risk ( s) ：受害drug product：藥物產(chǎn)品drug substance ：原料藥established 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

5、 compendium ：法定藥典（主要指USP、 NF） USP （the united state pharmacopeia）:美國藥典（現(xiàn)已和 NF合并一起 出版）NF （ national formulary ） ： （美國）國家藥品集official = pharmacopeial = 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 spe

6、cification:質(zhì)量管理規(guī)格標(biāo)準(zhǔn)（NDA1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）regulatory 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 ：食用補充品ICH （ International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human

7、 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 （SecondRevision）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 Design

8、s 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 Data對穩(wěn)定性數(shù)據(jù)的評估處理Q1F:Stability Data Package for Registration Applications inClimaticZones 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: Validatio

9、n of Analytical Procedures: Methodology 分析程序的驗證：方法學(xué)Q3A(R): Impurities in New Drug Substances (Revised Guideline)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 Solve

10、nts (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: Regulatory 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

11、:Quality of Biotechnological Products: Analysis of theExpressionConstruct in Cells Used for Production of r-DNA Derived ProteinProducts生物技術(shù)產(chǎn)品的質(zhì)量：源于重組DNA勺蛋白質(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Q

12、5D: Derivation and Characterisation of Cell Substrates Used forProduction of Biotechnological/Biological 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 ProductsSubject 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 Dru

13、g Substances and Products新原料藥和制劑的質(zhì)量規(guī)格Q6A: Specifications: Test Procedures and Acceptance Criteria forNew 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)

14、/ 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 Manufacturing Practice Guide for Active PharmaceuticalIngredients活性藥物成份的GMP旨南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 Carcinogen

15、icity Studies ofPharmaceuticals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)注釋的的補充S2A:Guidance on Specific Aspects of Regulato

16、ry Genotoxicity TestsforPharmaceuticals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 for 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 ofSystemicExposure 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:

17、Guidance for Repeated Dose TissueDistributionStudies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 Toxicity Tests單劑量毒性檢驗S4A: Duration of Chronic ToxicityTesting 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

18、生殖發(fā)育的毒性的檢驗S5B(M):Maintenance of the ICH Guideline on Toxicity to MaleFertility:An Addendum 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-DerivedPharmaceuticals生物技術(shù)生產(chǎn)的藥物的臨床前安全評價S7

19、A: Safety Pharmacology Studies for Human Pharmaceuticals人用藥的安全藥理學(xué)研究S7B:The Nonclinical Evaluation of the Potential for DelayedVentricularRepolarization(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): Ma

20、intenance of the ICH Guideline on Non-Clinical Safety Studies forthe Conduct of Human 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 forDrugsIntended for Long-Term Treatment of Non-Life-Threatening Conditions對用于無

21、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 Standards 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 CaseSafety Reports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(

22、E2B( M) )的修訂版E2B (M): Maintenance of the Clinical Safety Data Management including:Data 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 ManagementincludingQuestions and Answers臨床安全數(shù)據(jù)管理的變動，包括問答E2C:Clinical Safety Dat

23、a Management: Periodic Safety UpdateReports 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)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 andStandards 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: Pharmac

24、ovigilance Planning 藥物警戒計劃E3: Structure and Content of Clinical Study Reports 臨床研究報告的結(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

25、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)E8: 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 Investiga

26、tion of Medicinal Products in the PediatricPopulation小兒科藥物的臨床調(diào)查E12A: Principles for Clinical 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Mult

27、idisciplinary Guidelines多學(xué)科兼容的指南M1: Medical Terminology醫(yī)學(xué)術(shù)語M2:Electronic Standards for Transmission of RegulatoryInformation(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 co

28、mplete Status ofthe guidelines）通用技術(shù)文件（見有關(guān)CTDS節(jié)）M5: Data Elements and Standards for 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)獨立倫理委員會 倫理委員會IEC ： independent ethics