药学英语词汇目录注册、市场、法规、行政...............................................................................................................1补充1—制药行业..................................................................................................................22补充2--FDA,GMP,ICH英语词汇.........................................................................................32试剂、化学结构............................................................................................................................43工艺................................................................................................................................................57药剂................................................................................................................................................62补充1-药剂专业英语词汇....................................................................................................66补充2—药剂学英文词汇......................................................................................................72补充3—生物制药专业英语词汇..........................................................................................80MSDS(化学品安全技术说明书).............................................................................................94药物分析(含稳定性研究).........................................................................................................97补充1—药物分析................................................................................................................149数理统计......................................................................................................................................159补充1—统计学....................................................................................................................160包装、贮存..................................................................................................................................165药用拉丁文..................................................................................................................................167微生物检查..................................................................................................................................169免疫学..........................................................................................................................................173药理毒理、临床研究(含中医和拉丁词汇)...........................................................................186补充1—药理学词汇............................................................................................................210补充2—七年制药理学专业词汇表....................................................................................233补充3—药理学专业英语....................................................................................................247补充4—临床试验英语词汇................................................................................................297缩写..............................................................................................................................................3051注册、市场、法规、行政1906PureFoodandDrugsAct美国的《1906年食品和药品法》AbbreviatedNewDrugApplication(ANDA)简化新药申请。是FDA规定的仿制药申请程序Abstract文摘acceptancenotification受理通知书accommodateremarksandexplanations补充注释Acquisition收购activeingredient主成分ActivePharmaceuticalIngredient(API)(orDrugSubstance)活性药用成分(原料药)activepharmaceuticalingredient(API),activeingredient(AI),drugsubstance,bulkdrugs原料药ActivePharmaceuticalIngredients(API)活性药物成分研发机构APIAcuteToxicity急性毒性试验additionalsheets附页administrativeprotection行政保护adulterated伪劣的adversedrugreactionreporting药品不良反应报告affixtheofficialseal加盖公章afterexamination经审查agingcountry老龄化国家Aktiengesellschaft(A.G.)德语,为”股份公司“。公司名称中包括AG的主要是德国和瑞士,S.A.则主要出现在法国、瑞士、比利时、卢森堡、意大利、西班牙、葡萄牙、巴拿马、阿根廷、墨西哥和智利。aktieselskab(丹麦文),aktieselskab(挪威文)(A/S)股份有限公司。企业名称中出现A/S,一般可以定其为丹麦或挪威。allillegalmedicalpractices各种非法行医Alliance,Partnership合作Altiebolag(AB)瑞典语,“公司”。Amendment修正案AmericanMedicalAssociation美国医学会AmericanMedicalAssociation(AMA)美国医学会。1847年创建AmericanPharmaceuticalAssociation美国药物协会AmericanPharmaceuticalAssociation(APhA)美国药学会。1852年创建2AmericanSocietyofHospitalPharmacists美国医院药师学会AnalyticalMethod分析方法Animaltesting动物试验.在研究用动物身上进行的试验,主要是大白鼠和小白鼠,主要目的是预测某些物质在人体或动物身上的潜在副作用。APIStartingMaterial原料药的起始物料。用在原料药生产中的,以主要结构单元被并入该原料药的原料、中间体或原料药ApplicationForRegistration注册申请书applicationpending申请待批准approvalnumber批准文号approvedinformation批准信息AsdiscussedattheFDAPre-NDAmeeting如新药申请前与FDA会议中讨论的那样ASSISTANTCOUNSEL助理巡视员ASSISTANTMINISTER部长助理ASSTANTCONSULTANT助理调研员Basedontherequirementtoensurepublichealth,SFDAmayimplementamonitoringperiodfortheapprovednewdrugssoastocontinuetomonitorthesafetyofthenewdrug.Thedrug-monitoringperiodshallstartfromthedateofapprovalforproduction,andshallnotexceed5years.Forthenewdrugsunderthemonitoringperiod,SFDAshallnotapproveproduction,dosagechangeandimportationofthedrugbyotherenterprises.国家食品药品监督管理局根据保护公众健康的要求,可以对批准生产的新药品种设立监测期。监测期自新药批准生产之日起计算,最长不得超过5年。监测期内的新药,国家食品药品监督管理局不批准其他企业生产、改变剂型和进口。batchcertification批认证BatchNumber(orLotNumber)批号batchrelease批号发放bechemicallydescribedas化学名为beinvolvedinoneofthestepsofth