制药工程专业英语Unit5【爆款】.ppt

优选 优选 优选 优选 优选 The professional English of pharmaceutical engineering Wang Xinliang East China university of science and technology 05.03.2012 * Words attrition rate indications new chemical entities differentiation formulary toxicity toxicology dossier dosage form synergism antagonism genotoxicology carcinogenicity abnormality pharmacy pharmacognosy pharmacodynamics pharmacokinetics pharmacotherapeutics 淘汰率 n. 适应症 新化学实体（新化合物） n. 区别；变异 n. 公式集；处方集 n. 毒性 n. 毒物学；毒理学 n. 档案，卷宗；病历表册 剂型；药物剂型 n. 协调作用 n. 拮抗作用(反协调作用) n. 基因毒理学 n. 致癌性；致癌毒性 n. 异常；畸形 n. 药剂学；制药业 n. 生药学 n. 药效学 n. 药物(代谢)动力学 n. [临床]药物治疗学 * 1.引言 药品开发是一个非常复杂的过程，需要在广泛的不同功能性团队之间进行大量的协调和沟通。这个过程是昂贵的，特别是在临床开发的后期阶段，其中涉及到对数百名病人的研究。据目前的估计，一个新药的开发成本约2.3亿美元（1987年的美元），并且从起动临床前的开发阶段到首次上市（不包括监管延迟），需要花费7-10年。 1. Introduction Drug Development is a very complex process requiring a great deal of coordination and communication between a wide range of different functional groups. It is expensive, particularly in the later phases of clinical development, where studies involve hundreds of patients. It is currently estimated that the development of a new drug costs about $ 230 million (1987 dollars) and takes somewhere between 7 and 10 years from initiation of preclinical development to first marketing (excluding regulatory delays). Unit 5 Drugs Development (I) * 药物开发是一项高风险业务，虽然（淘汰）比率不断上升，在完成了首次人体研究的每十个新化学实体中，大约只有一个会成为产品。随着候选药物开发的进行，失败的风险在前进的道路上，会象跨栏似的降低。失败的典型原因包括：不可接受的毒性，缺乏功效，或不比竞争产品有优势（图1）。 Drug development is a high-risk business; although the rate is increasing, only about ONE out of every TEN new chemical entities studied in human beings for the first time will ever become a product. As a drug candidate progresses through development the risks of failure decrease as ‘hurdles’ are overcome along the way. Typical reasons for failure include unacceptable toxicity, lack of efficacy, or inability to provide advantages over competitive products (Fig. 1). * 图1. 淘汰率和终止的原因 Attrition Rate of New Chemical Entities (NCE‘