制药工程专业英语--5单元

制药工程专业英语--5单元

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 studies 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 between7and10years 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 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).

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 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 profile 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 refined 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, which 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