药学英语07-Unit-Eight2014

LOGOPharmaceuticalAdministrationUnitEight:Pharmacoeconomics3Review&Pre-view4(I)abbreviatednewdrugapplication(ANDA)（仿制药）简化新药申请abuse滥用acceleratedreview加速”审批“acceptandregister受理与立案acceptance验收，接收adoptedname药品通用名(II)adulterate/adulteration掺假adversedrugreaction(ADR)药品不良反应approvalofanewproduction新药生产审批approveandawardacertificate批准与授予证书biologicalproducts生物制品，生物产品biologics生物技术药物(III)biostatistics生物统计学bloodbank血库Bureau局，处CDER医药评价与研究中心CFSAN食品安全及应用营养中心clinicalstudies/trials临床试验(IV)compoundpreparation复方制剂contract合同ControlofClinicalTrialAct临床试验管理法cosmetics化妆品counterfeitdrug假药CriminalLaw刑法(V)deputycommissioner副局长disciplineofpharmaceuticaladministration药事管理学科DivisionofPoisonControl毒物控制处drugabusetreatmentmonitoring药物滥用治疗监管drugadministration药品管理drugapprovalnumber药品批准文号(VI)drugcertification药品认证drugclassification药品分类drugdistributor药品经营企业drugexportlicense出口药品许可证druglicense药品注册，药品执照drugtrademark药品商标(VII)establishmentlicense（药品）营业执照facility设施genuineChinesecruddrug地道药材LawonMedicalDevices《医疗器械法》LawonProductQuality《产品质量法》MedicineAct/Law《药品法》(VIII)nameusedtoindicatepast曾用名nationaldrugstandards国家药品标准packageinsert药品说明书packagingmaterials包装材料pharmaceuticaladministration(science)药事管理（学）PharmacopoeiaofthePeople’sRepublicofChina《中华人民共和国药典》(IX)PharmacyAdministrationCommittee药事管理委员会qualitycontrol(QC)质量控制RegulationforImplementationoftheDrugAdministrationLawofthePeople’sRepublicofChina《中华人民共和国药品管理实施条例》specification规格withdrawalsyndrome截断症状WhatisGMP?Paragraph1USA/GMPregulationsParagraph2-15EU/UKGMPrequirementsParagraph16-18USA/EUGMPdifferencesParagraph19-23Thereasonwhyweneedpharmacoeconomics(Paragraph1-4)Overviewofcost-benefitandothereconomicmethods(Paragraph5)Cost-benefitanalysis(Paragraph6-12)Cost-effectivenessanalysis(Paragraph13)Calculationsforapharmacoeconomicconsult(Paragraph14)cost-benefitanalysis成本效益分析parenteral非口服的cost-effectivenessanalysis成本效益分析NotesP321时间：晚上6:30词汇题（单选题）2x25=50阅读理解（单选题）2x10(2Passages)=20翻译题（主观题）5x6=30LOGO