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1、P54-专业英语作业 1. Drug Development is a very complex process requiring a great deal of coordination and communication between a wide range of different functional groups.中文翻译:药物开发是一个十分复杂的过程，需要在广泛的不同功能性团队之间进行大量的协调与沟通。 2. It is expensive, particularly in the later phases of clinical development, where stu
2、dies involve hundreds of patients 这个过程（药物开发）这是昂贵的，特别是在临床开发的后期阶段，其中涉及到对数百名患者的研究。 3. It is currently estimated that the development of a new drug costs about $230 million and takes somewhere between 7 and 10 years form initiation of preclinical development to first marketing. 目前估计,一种新药的开发成本约为2.3亿美元,并且
3、从启动临床前的开发阶段到首次上市，需要花费7到10年4. 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. 药物开发是一个高风险的业务，尽管比率在不断上升，但是在完成了首次在人体研究中的每十个新化学实体中，大约只有一个能成为产品。5.原文：As a
4、drug candidate progresses through development the risks of failure decrease as hurdles are overcome along the way.翻译：随着候选药物开发的进行，失败的风险在前进夫人道路上，会像跨栏似的降低。6.Typical reasons for failure include unacceptable toxicity , lack of efficacy , or inability to provide advantages over competitive products(Fig.1)
5、.翻译：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。7. Assessment of whether a drug candidate is likely to provide competitive advantages highlights the need first to have in place a set of product goals or target product profile.对候选药物是否可能提供有竞争性优势方面的评估，首先需要强调的是应达到一系列产品目标或目标产品的特性。 8 、Particular attention should be
6、 paid to the differentiation from competitors.应该特别注意竞争者（指药物）之间的差异。9、This is becoming more and more critical with the increasing emphasis on limited formularies，healthcare costs， and pharmacoeconomics (discussed later in the chapter). 随着对有限的处方、医疗保健费用以及药品经济学的日益关注，这种情况变得越来越重要（本章稍后讨论）。10. A target profi
7、le will define the indication (s) that a drug candidate will be developed for, along with goals such as once a day dosing, faster onset of action, better side effect profile than a major competitor. 包括诸如每日一次给药、起效更快、比主要竞争者具有更低的毒副作用的特性等目标在内，药物开发的目的特性将定义候选药物被开发的疾病适应症。11. The target profile can be refin
8、ed and revised as a drug candidate moves through development and new data on the drug candidate or competitors become available. 随着候选药物的开发阶段的进展，以及候选药物或竞争药物新数据的获得，药物开发的目的特性可以再定义或修改。12；The logical next steps are to define the development strategy, for example , which indications to develop first, whic
9、h countries to aim to market the drug in and then to define the core clinical studies necessary to achieve regulatory approval and commercial success.翻译：合乎逻辑的下一个步骤就是明确开发战略，例如，哪个疾病适应症要优先开发，以哪些国家作为药物的目标市场，然后确定能获得监管部门的批准和商业成功的必要核心临床研究。13.原句：This chapter will describe the main activities required for su
10、ccessful development of a new drug.翻译：本章将描述一个新药成功开发过程所需的主要活动 。14.原文：All these activities, many of which are interdependent, need to be carefully planned and co-ordinate翻译：所有的这些动，其中许多都是相互依存的，需要认真规划和协调15. Speed to market with collection of high quality data is critical for success中文翻译: 快速向市场收集高质量的数据是成
11、功的关键。16. The path of activities which determine the time it will take to get to registration is called, in project management terms, the critical path.确定需要测定花费的时间来获得登记的活动的步骤，以项目管理术语而言，被称为关键步骤。17. It is vital to plan and prepare before studies begin and to monitor and manage problems so as to ensure
12、that the critical path remains on schedule.译：在研发开始之前，计划和准备，并监控和管理问题以及确保关键步骤如期进行，这是非常重要的，。 18.原文：With increased economic pressures and competitive intensity it is important for companies to explore ways to shorten this critical path翻译：由于经济压力和竞争强度的增加，企业探索如何缩短这一关键步骤是重要的。19.Running activities in paralle
13、l, or overlapping studies which would usually run sequentially , often involves an increase in risk but the dividends in time-saving can make such strategies worthwhile.译文：并行开展这些活动，或将通常按顺序开展的研究进行重叠，往往会涉及到风险的增加；但节省时间的红利可以使这种战略值得这样做。20.Thecriticalpathfordevelopmentofanewdruggenerallyrunsthroughtheinit
14、ialsynthesisofcompound,subacutetoxicologystudies,andthentheclinicalprogram. 新药开发的关键步骤贯穿于化合物的初期合成、亚急性毒理学研究和随后的临床计划。21.A chart showing the critical path activities for a typical drug candidate is shown in Fig翻译: 一个展示典型的候选药物的关键步骤活动的图所示。22、The following sections highlight the objectives and activities o
15、f drug development work.下列各部分突出了和药物开发工作的具体目标和活动内容23、Activities within each technical discipline are described broadly in chronological order.在每个技术学科里的活动按时间先后排列的顺序大致作了介绍。24At any one time, work in the all these disciplines may be proceeding in parallel.翻译：在任何时候，所有这些领域的工作可能是平行进行。25.原文：The timing and outcome of much of the work has direct impact on work in other disciplines.翻译：这些大多数工作的时序和所出成果对其他学科里的工作有着直接的影响。26、 The major phases of drug development are Preclinical (studies required before the compound can be dosed in humans), Phase I (clinical studies usually in he
