制药工程专业英语--5单元.docx

P54-专业英语作业1. DrugDevelopmentisaverycomplexprocessrequiringagreatdealofcoordinationandcommunicationbetweenawiderangeofdifferentfunctionalgroups.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. Itisexpensive, particularlyinthelaterphasesofclinicaldevelopment, wherestudiesinvolvehundredsofpatients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. Itiscurrentlyestimatedthatthedevelopmentofanewdrugcostsabout $230millionandtakessomewherebetween7and10yearsforminitiationofpreclinicaldevelopmenttofirstmarketing. 目前估计,一种新药的开发成本约为2.3亿美元,并且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. Drugdevelopmentisahigh-riskbusiness; althoughtherateisincreasing, onlyaboutoneoutofeverytennewchemicalentitiesstudiedinhumanbeingsforthefirsttimewilleverbecomeaproduct. 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：Asadrugcandidateprogressesthroughdevelopmenttherisksoffailuredecreaseas ‘hurdles’ areovercomealongtheway.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.Typicalreasonsforfailureincludeunacceptabletoxicity , lackofefficacy , orinabilitytoprovideadvantagesovercompetitiveproducts(Fig.1).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. Assessmentofwhetheradrugcandidateislikelytoprovidecompetitiveadvantageshighlightstheneedfirsttohaveinplaceasetofproduct goals ortargetproductprofile.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、Particularattentionshouldbepaidtothedifferentiationfromcompetitors.应该特别注意竞争者（指药物）之间的差异。9、Thisisbecomingmoreandmorecriticalwiththeincreasingemphasisonlimitedformularies，healthcarecosts，andpharmacoeconomics (discussedlaterinthechapter). 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. Atargetprofilewilldefinetheindication (s) thatadrugcandidatewillbedevelopedfor, alongwithgoalssuchasonceadaydosing, fasteronsetofaction, bettersideeffectprofilethanamajorcompetitor. 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. Thetargetprofilecanberefinedandrevisedasadrugcandidatemovesthroughdevelopmentandnewdataonthedrugcandidateorcompetitorsbecomeavailable. 随着候选药物的