制药工程专业英语--5单元

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 o

16、utcome 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 healthy human volunteers), Phase (

17、 initial efficacy and safety and dose finding studies in patients)，and Phase (studies in several hundred patients).药物开发的主要阶段是临床前期（化合物可给人体服药前的所需的研究）、I阶段（通常在健康志愿者身上的临床研究）、期（病人身上的初期疗效和安全性和治疗剂量调查研究）和期（在几百个病人的研究）。27.原文：There then follows assembly of a marketing application dossier for subsequent review b

18、y country regulatory authorities.翻译 ：然后附述一个由国家监管当局随后审查的上市申请档案的汇编。28、 Rapid development of a drug candidate is dependent on the availability of sufficient quantity of the compound. 候选药物的快速开发是取决于足够数量的化合物的可获得性。29.The purity of compound needs to reach certain standards in order for it to be used in safe

19、ty （toxicology),pharmaceutical, and clinical studies.该化合物的纯度需要达到一定的标准，以便它用于安全性（毒理学）、药理学和临床的研究。30.Initially , chemists will work on a small to medium scale to investigate production of the compound by several different methods so as to identify the optimum route for synthesizing the compound最初，化学家将进行

20、小到中等规模的研究，考察采用几种不同方法制备该化合物，以便确定该化合物的最佳合成路线。31原句:Optimun here may mean a combination of several factors, for example, most efficient, cheapest safe, or that producing minimal waste.翻译:这里“最佳” 可能意味着多种因素的组合，例如，最有效，最便宜的安全，或产生最少的废物。32. Analysis of the final product as well as intermediates and impurities

21、plays a key role in identifying the best method of synthesis 最终产品和中间体及杂质的分析在确定最佳的合成方法起着关键作用33.Developmentandvalidationofanalyticalmethodsarenecessarytosupportprocessdevelopmentandguaranteethepurityofthedrugsubstance译：分析方法的开发和验证对于支持工艺开发和保证原料药的纯度是必要的。34. In some cases levels of impurities may be unacc

22、eptably high and either improved purification procedures will need to be developed or the synthetic process may require significant alterations.在某些情况下，杂质的含量可能高得令人无法接受，要么需要开发改进的纯化程序，要么需要对合成过程大量调整35. The main aim is to ensure that the composition of compound is understood and that ultimately the mater

23、ial that is prepared is as pure as possible.其主要目的是确保化合物的成分，最终所制备的物料尽可能的纯净。36. As a drug candidate progresses through development, larger and larger amounts of compound are required 随着候选药物开发的进展，所需化合物的数量越来越多37、 The amount of material required for different tests will often depend on the actual potency

24、 and dosage form of the compound. 不同测试所需的物料的数量，往往取决于化合物的实际效力和剂型。38. A pilot plant can be regarded as a mini-manufacturing set-up中试工厂可以被看作是一个小型规模的制造机构。39、before transferring to a pilot plant, extensive evaluation and testing of the chemical synthesis is undertake to ensure that any changes and hazard

25、s are minimized.译：在转入中试工厂前，需要对化学合成进行广泛的评估和测试，以确保任何的改变和危害降至最低。40Procedures are optimized，particular attention being paid to developing environmentally acceptable ways of disposing of waste products.（制备）程序要优化，特别注重开发环境可接受的处置废弃物的方法。 41、 Commercial production of bulk drug substance for production of a dr

26、ug，once approved and marketed，will likely take place on a larger scale or at a registered manufacturing plant.翻译：一旦被批准和销售，药品生产所用的大量原料药，其商业化生产将可能采取更大规模进行或在登记的制造工厂进行。42、The dosage form of a drug is the form by which it is administered to the patient. 药物的剂型，是指病人服用药物的方式。43 There are a vast array of poss

27、ible dosage forms ranging from transderal patches to inhalers to intranasal medicines有大量从透皮贴片到滴鼻药的可能剂型。44.Themorecommondosageformsincludeoraltabletsorcapsles,oralliquids,topicalointmentsorcreams,andinjectables.较常见的剂型包括口服片剂或胶囊、口服液、局部药膏或霜剂、和注射剂。45.The dosage form or forms chosen for a particular drug

28、candidate will be defined in the target profile.特定候选药物剂型或形态的选择会在将目标特性中被定义。46.Sometimes a more simple dosage form, for example an oral solution, is chosen for early clinical studies in human beings.有时，一个更简单的剂型，例如含片，会被选择来进行早期人类临床研究。47. This may save time and upfront costs at an early , high-risk stage

29、 of the drug development process. 在药物开发过程中早期、高风险的阶段，这（早期临床研究）可以节省时间和预付成本48.later clinical studies would use the expected marketed dosage form 后期的临床研究将用到预期要销售的剂型。49.whateverthedosageform,thecombinationofdrugandothermaterialswhichconstituteitmustfulfilcriteria 无论是什么剂型，药物和其他（构成药物的）原料的组合必须符合标准。50、One of

30、 the most important is that of adequate stability 最重要的标准之一是有足够的稳定性。51.That means a predetermined potency level must remain after，for example ，two or three years 这意味着，预先确定的效力水平必须，例如，两年或三年后，能继续保持。52. The stability data generated on a dosage form will determine its shelf-life and recommended storage co

31、ndition.一种剂型所产生的稳定剂数据将决定它的保质期和推荐的储存条件。53.Early in development the shelf-life may be limited to several months.在开发的早期，其保质期可能仅限于数月。54.Thiswillnotbeaproblemprovideditissufficienttocoveruseofthedrug overthedurationoftheclinicalstudyorstudies.翻译：只要药品的使用期限足以超过临床研究或研究的阶段，这（保质期）就不会是个问题。55.Beforeadrugcandida

32、teisgiventoman,itspharmacologicaleffectsonmajor systemsareofteninvestigatedinanumberofspecies. 在候选药物给人服用之前，它关于主要系统的药理作用往往在大量的物种上进行了研究。56.the body systems studied include cardiovascular ,respiratory ,and nervous systems ;the effects on gross behavior can also be studied所研究的身体系统包括心血管系统，呼吸系统和神经系统；对总体行为

33、的影响也会研究。57、 Experiments are sometimes conducted to see whether the drug candidate interferes with the actions of other medicines which, because of their specific effects or because of their common use, are likely to be taken concurrently with the drug candidate进行实验有时是为了观察候选药物是否对其他药物的作用有干扰，由于这些药物的特殊的

34、作用或者因为它们的普遍使用，它们可能要与候选药物同时服用。58Any synergism or antagonism of drug effects should be investigated, and any necessary warning issued to clinical investigators.应当对药物的任何协同作用或拮抗作用进行研究，任何必要的警告都应该告诉临床研究者。59.It may be judged necessary to investigate such effects further in clinical studies , and any potent

35、ial or proven drug interactions are likely to be noted in the product labeling for the drug这可能会用来被判断在临床研究进一步研究这些作用的必要性，且任何潜在的或已被证明的药物相互作用都可能记录在药物的说明书上。60. It may also be appropriate to identify a substance for possible use in the management of overdosage , particularly if the therapeutic margin of t

36、he drug candidate is small.翻译：特别是如果该候选药物的治疗范围很小时，确定一种物质在过剂量的管理规范下的可能用法，这也可能是适当的。62、 The objective of animal toxicology testing, carried out prior to the administration of a drug to man, is to reject compounds of unacceptable toxicity and to identify potential target organs and timings for adverse ef

37、fects of the drug.在药品开给人服用前所开展的动物毒理学测试的目的，是为了排除不可接受的毒性化合物，识别潜在的靶器官和药物不良反应的时序。63.Thismeansthatinearlyhumanstudiestheseorgansandtissuescanbemonitoredwithparticularattention.这就意味着，在早期人类研究中这些器官和组织可以特别注意而得到监测。64. it is important to establish whether toxic effects are reversible or irreversible ,whether t

38、hey can be prevented and if possible,the mechanism of the toxicological effects 对有毒作用是可逆的还是不可逆转的、它们是否可以预防的、（如果可能的话）毒理学作用机制的确定，是重要的。65、 It is also important to interrelate drug response to blood levels in humans and blood levels in various animals pecies. 使药物在人类的血中浓度和各种动物物种的血中浓度的响应建立相互关联也是重要的。66. The

39、 toxicological studies required for the evaluation of a drug candidate in man will be relevant to its proposed clinical use in terms of, route of administration and duration of treatment of the clinical studies.对于在人候选药物评价所需的毒理学研究，将与所推荐的临床应用时的给药途径和临床研究的治疗持续时间有关。67.原文：The size and frequency of the dos

40、es and the duration of the toxicology studies are major determinants of permissible tests in man.翻译：剂量的大小和使用频率，以及毒理学研究的持续时间是人体获准测试的主要决定因素。68.Countries , including UK,USA, Australia, and Nordic countries, have regulatory guidelines which relate the duration of treatment allowed in man to the length o

41、f toxicity studies required in two species.翻译：许多国家，包括英国、美国、澳大利亚和北欧国家，都有涉及在人类治疗持续时间和需要在两个物种中进行毒性研究时间长短的监管指南。69. Points from the guidelines are referenced in the subsequent sections.指南的要点引用在随后的章节里。70. Initially, the pharmacological effects of increasing doses of the test substances are established in

42、acute toxicity studies in small numbers of animals, generally using two routes of administration (one being that used in man).最初，增加测试物质剂量的药理作用建立于少量动物的急性毒性研究，一般采用两种给药途径（一种用于人体）。71.Results provide a guide to the maximum tolerated doses in subsequent chronic toxicity tests, aid selection of does levels

43、, and identify target organs.翻译：（所得的）结果给随后的慢性毒性试验，提供了一个最大耐受剂量的参考值，有助于剂量水平的选择，以及确定靶标器官。72.The main aim of the subsequent sub-acute toxicity tests is to determine whether or not the drug candidate is adequately tolerated after administration to animals for a prolonged period as a guide to possible adv

44、erse reactions in man.随后的亚急性毒性试验的主要目的是确定候选药物在动物长期给药后是否有足够的耐受性，从而作为对人类可能产生的不良反应的参考。73.Two to four week (daily dosing) studies are requird, using the same route of administration as in man, in two species (one non-rodent) prior to administration of the compound to man. 使用与人相同的给药途径，在先于人的该化合物的给药前，两个物种（一

45、个为非啮齿类）的两到四个星期（每日剂量）的研究是必需的。74:Three does levels are usually necessary : the low daily does should be a low multiple of the expected therapeutic does , and the highest does should demonstrate some toxicity. 翻译：三个剂量水平通常是必要的：每天的低剂量应是所期望的治疗剂量的低一数量级，最高剂量应显示出一定的毒性。75.原文：A general guide for the evaluation

46、 of new chemical entities would be that toxicology studies of a minimum duration of 14 days are required to support single-does exposure of a new drug candidate in normal volunteers in phase 1.翻译：评价新化学实体的通用指南应该是一个为期14天以上毒理学研究需要支持正常的志愿者在第I阶段的单剂量接触一个新的候选药物。76. Toxicology studies of 30 days duration ar

47、e required to support clinical studies of 7 to 10 days duration.翻译：7-10天的临床研究则需要30天的毒理学研究来支持77.Clinical studies of greater than 7 to 10 days up to 30 days duration require the support of at least 90 days toxicology studies.而超过7至10天直至30天的临床研究则需要有至少90天的毒理学研究来支持。Clinical studies 临床研究； toxicology studie

48、s 毒理学研究78.:These requirements illustrate the need to plan ahead in drug development中文翻译: 这些要求应在计划药物开发之前就明确说明。79、 The duration and approximate timings for future clinical trials need to be considered well in advance in order to schedule and conduct the appropriate toxicology studies to support the cl

49、inical program and avoid any delays.未来临床试验的持续时间和大概的时序安排需要提前好好地深思熟虑，以便做好安排并进行适当的毒理学研究，以支持临床计划并避免任何延误。80.原文：Two types of safety test are used to detect the ability of the drug candidate to produce tumours in man.翻译：两种类型的安全测试是用来检测候选药物在人体引起肿瘤的能力。81.英语原文：The first are shortterm in vitro genotoxicity test

50、s, for example bacterial tests.译文：第一类是短期的体外遗传毒性试验，例如细菌试验。82.Thesecondarelong-termanimalcarcinogenicitystudieswhichareconductedinmiceandrats;theirlengthofoften2yearscoversalargepartofthelifespanoftheanimal第二类是在小鼠和大鼠身上进行的动物长期致癌性研究；他们往往在两年的时间长度覆盖了动物寿命的很大一部分。83.原句:Mice and rats are used because of their relative 知识，大大有助于解释研究结果。85.long-term toxicology and carcinogenicity studies are conducted in