【正文】 P54專業(yè)英語作業(yè) 1. Drug Development is a very plex process requiring a great deal of coordination and munication between a wide range of different functional groups.中文翻譯:藥物開發(fā)是一個十分復(fù)雜的過程，需要在廣泛的不同功能性團(tuán)隊之間進(jìn)行大量的協(xié)調(diào)與溝通。 2. It is expensive, particularly in the later phases of clinical development, where studies involve hundreds of patients 這個過程（藥物開發(fā)）這是昂貴的，特別是在臨床開發(fā)的后期階段，其中涉及到對數(shù)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. 目前估計,并且從啟動臨床前的開發(fā)階段到首次上市，需要花費7到10年4. Drug development is a highrisk 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 bee a product. 藥物開發(fā)是一個高風(fēng)險的業(yè)務(wù)，盡管比率在不斷上升，但是在完成了首次在人體研究中的每十個新化學(xué)實體中，大約只有一個能成為產(chǎn)品。：As a drug candidate progresses through development the risks of failure decrease as ‘hurdles’ are overe along the way.翻譯：隨著候選藥物開發(fā)的進(jìn)行，失敗的風(fēng)險在前進(jìn)夫人道路上，會像跨欄似的降低。 reasons for failure include unacceptable toxicity , lack of efficacy , or inability to provide advantages over petitive products().翻譯：失敗的典型原因包括：不可接受的毒性,缺乏功效,或不比競爭產(chǎn)品有優(yōu)勢。7. Assessment of whether a drug candidate is likely to provide petitive advantages highlights the need first to have in place a set of product 39。goals39。 or target product profile.對候選藥物是否可能提供有競爭性優(yōu)勢方面的評估，首先需要強(qiáng)調(diào)的是應(yīng)達(dá)到一系列產(chǎn)品目標(biāo)或目標(biāo)產(chǎn)品的特性。 8 、Particular attention should be paid to the differentiation from petitors.應(yīng)該特別注意競爭者（指藥物）之間的差異。This is being more and more critical with the increasing emphasis on limited formularies，healthcare costs， and pharmacoeconomics (discussed later in the chapter). 隨著對有限的處方、醫(yī)療保健費用以及藥品經(jīng)濟(jì)學(xué)的日益關(guān)注，這種情況變得越來越重要（本章稍后討論）。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 petitor. 包括諸如每日一次給藥、起效更快、比主要競爭者具有更低的毒副作用的特性等目標(biāo)在內(nèi)，藥物開發(fā)的目的特性將定義候選藥物被開發(fā)的疾病適應(yīng)癥。11. The target profile can be refined and revised as a drug candidate moves through development and new data on the drug candidate or petitors bee available. 隨著候選藥物的開發(fā)階段的進(jìn)展，以及候選藥物或競爭藥物新數(shù)據(jù)的獲得，藥物開發(fā)的目的特性可以再定義或修改。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 mercial success.翻譯：合乎邏輯的下一個步驟就是明確開發(fā)戰(zhàn)略，例如，哪個疾病適應(yīng)癥要優(yōu)先開發(fā)，以哪些國家作為藥物的目標(biāo)市場，然后確定能獲得監(jiān)管部門的批準(zhǔn)和商業(yè)成功的必要核心臨床研究。：This chapter will describe the main activities required for successful development of a new drug.翻譯：本章將描述一個新藥成功開發(fā)過程所需的主要活動 。：All these activities, many of which are interdependent, need to be carefully planned and coordinate翻譯：所有的這些動，其中許多都是相互依存的，需要認(rèn)真規(guī)劃和協(xié)調(diào)15. Speed to market with collection of high quality data is critical for success中文翻譯: 快速向市場收集高質(zhì)量的數(shù)據(jù)是成功的關(guān)鍵。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.確定需要測定花費的時間來獲得登記的活動的步驟，以項目管理術(shù)語而言，被稱為關(guān)鍵步驟。17. It is vital to plan and prepare before studies begin and to monitor and manage problems so as to ensure that the critical path remains on schedule.譯：在研發(fā)開始之前，計劃和準(zhǔn)備，并監(jiān)控和管理問題以及確保關(guān)鍵步驟如期進(jìn)行，這是非常重要的。 ：With increased economic pressures and petitive intensity it is important for panies to explore