欧洲药典适用性证明文件CEP, certificate of suitability to the monographs of the European pharmacopeia
药品主文档 DMF,drug master file
医学内照射剂量 MIRD,medical internal radiation dose
药品注册 registration of pharmaceuticals
药品评价 evaluation of pharmaceuticals
药品认证 certification of pharmaceuticals
世界贸易组织 WTO,world trade organization
药品 drug
活性药物成分 active pharmaceutical ingredient
药物制剂,制剂 pharmaceutics
试验用药品 investigational product
世界卫生组织 WHO, world health organization
注册证书 registration certification
产品执照 product license
销售许可证 marketing authorization
毒理学 toxicology
伦理委员会 Ethics Committee
免疫原性 immunogenicity
Me Too药物又称”模仿”药
先导化合物 lead compound
生物等效性实验bioequivalence test
临床试验 clinical trial
新化学实体,新化合物实体 NCE,new chemical entity
(药物)上市监测 post marketing surveillance, PMS
实验 experiment, test
试验 test,trial,experiment
药物非临床研究质量管理规范 GLP,good laboratory practice
药物临床试验质量管理规范 GCP,good clinical practice (国外也有人将GCP称为GCRP,good clinical research practice)
药品生产质量管理规范 GMP,good manufacturing practice
中药材生产质量管理规范 GAP,good agriculture practice
药品经营质量管理规范 GSP,good supply practice
盲法 blind method
欧洲共同体,欧共体 European Community, EC
国际药品管理机构会议 ICDRA,International Conference of Drug Regulatory Authorities
国际制药工业协会联合会 IFPMA,International Federation of Pharmaceutical Manufacturers Associations
欧洲制药工业协会联合会 EFPIA,European Federation of Pharmaceutical Industries Associations
专家工作组 expert working groups, EWG
欧洲联盟 European Union,EU
日本厚生省 MHW,Japan Ministry of Health and Welfare