药学英语07 Unit Eight2014课件

1、Pharmaceutical AdministrationUnit EightContentsSpecial Terms1Text A: Good Manufacturing Practice2 Text B: Pharmacoeconomics3Review & Pre-view 4LOGOSpecial Terms (I) abbreviated new drug application (ANDA) （仿制药）简化新药申请 abuse 滥用 accelerated review 加速”审批“ accept and register 受理与立案 acceptance 验收，接收 adopt

2、ed name 药品通用名 LOGOSpecial Terms (II) adulterate/ adulteration 掺假 adverse drug reaction (ADR) 药品不良反应 approval of a new production 新药生产审批 approve and award a certificate 批准与授予证书 biological products 生物制品，生物产品 biologics 生物技术药物 LOGOSpecial Terms (III) biostatistics 生物统计学 blood bank 血库 Bureau 局，处 CDER 医药评

3、价与研究中心 CFSAN 食品安全及应用营养中心 clinical studies/trials 临床试验 LOGOSpecial Terms (V) deputy commissioner 副局长 discipline of pharmaceutical administration 药事管理学科 Division of Poison Control 毒物控制处 drug abuse treatment monitoring 药物滥用治疗监管 drug administration 药品管理 drug approval number 药品批准文号LOGOSpecial Terms (VI)

4、drug certification 药品认证 drug classification 药品分类 drug distributor 药品经营企业 drug export license 出口药品许可证 drug license 药品注册，药品执照 drug trademark 药品商标LOGOSpecial Terms (VIII) name used to indicate past 曾用名 national drug standards 国家药品标准 package insert 药品说明书 packaging materials 包装材料 pharmaceutical administr

5、ation (science) 药事管理（学） Pharmacopoeia of the Peoples Republic of China 中华人民共和国药典 LOGOSpecial Terms (IX) Pharmacy Administration Committee 药事管理委员会 quality control (QC) 质量控制 Regulation for Implementation of the Drug Administration Law of the Peoples Republic of China 中华人民共和国药品管理实施条例 specification 规格 w

6、ithdrawal syndrome 截断症状 LOGOTextsText A: GMP What is GMP? Paragraph 1 USA/GMP regulations Paragraph 2 - 15 EU/UK GMP requirements Paragraph 16 - 18 USA/EU GMP differences Paragraph 19-23 LOGOWords & Phrases cost-benefit analysis 成本效益分析 parenteral 非口服的 cost-effectiveness analysis 成本效益分析Notes P321LOGOF