外观

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