研究与开发 R&D,research and development
新药发现 medicine discovery
新药发展 medicine development
上市 marketing
新分子药物 new molecular entity, NME
计算机辅助药物设计 computer aided drug design, CADD
组合化学 combinatory chemistry
高通量筛选 high throughout screening
ADME,吸收absorption,分布distribution,代谢metabolism,排泄excretion
临床研究用新药 investigational new drug, IND
新药研究申请 investigation of new drug,IND
注册新药,新药申请 new drug application, NDA
风险 risk
专利 patent
专利法 Patent Act
与贸易有关的知识产权协议 TRIPS,Agreement on Trade-related Aspects of Intellectual Property Right
发明 invention
新颖性 novelty
现有技术 the state of the art
创造性或进步性 inventive step,又称先进性 inventiveness
实用性 utility
公共秩序 public policy
实施动植物卫生检疫措施协议 SPS,Agreement On The Application Of Sanitary And Phytosanitary Measures
技术性贸易壁垒协议 TBT,Technical Barriers to Trade
关贸总协定,关税及外贸总协定 GATT,General Agreement on Tariffs and Trade
服务贸易总协定 GATS,General Agreement on Trade in Services
侵权 infringement
共同侵权 contributory infringement或joint infringement
西咪替丁 cimetidine
卡托普利 captopril
柜台药,非处方药物 over the counter,OTC
双单侧检验 two one-side test
罕见病用药物,奥芬药物 orphan drug
罕见药物法案 Orphan Drugs Act
药品批准依据总结 SBA,Summary Basis for Approval
先用权 priority
OEM,original equipment manufacturing (直译为“原创设备加工”),意为国外的原创,国内的设备加工。
临床前研究 preclinical studies
非临床研究 nonclinical studies (在学术界,“非临床研究”与“临床前研究”这两个术语名词是通用的。)