【正文】 身上的臨床研究）、Ⅱ期（病人身上的初期療效和安全性和治療劑量調查研究）和Ⅲ期（在幾百個病人的研究）。 chart showing the critical path activities for a typical drug candidate is shown in Fig翻譯: 一個展示典型的候選藥物的關鍵步驟活動的圖所示。thenofthroughnewfor activities in parallel, or overlapping studies which would usually run sequentially , often involves an increase in risk but the dividends in timesaving can make such strategies worthwhile.譯文：并行開展這些活動，或將通常按順序開展的研究進行重疊，往往會涉及到風險的增加；但節(jié)省時間的紅利可以使這種戰(zhàn)略值得這樣做。：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，需要認真規(guī)劃和協(xié)調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量的數(shù)據是成功的關鍵。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在內，藥物開發(fā)的目的特性將定義候選藥物被開發(fā)的疾病適應癥。goals39。 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)是一個高風險的業(yè)務，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實體中，大約只有一個能成為產品。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)是一個十分復雜的過程，需要在廣泛的不同功能性團隊之間進行大量的協(xié)調與溝通。：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)的進行，失敗的風險在前進夫人道路上，會像跨欄似的降低。 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，首先需要強調的是應達到一系列產品目標或目標產品的特性。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)階段的進展，以及候選藥物或競爭藥物新數(shù)據的獲得，藥物開發(fā)的目的特性可以再定義或修改。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，以項目管理術語而言，被稱為關鍵步驟。developmentdrugthepound,subacutethe2The following sections highlight the objectives and activities of drug development work.下列各部分突出了和藥物開發(fā)工作的具體目標和活動內容2Activities within each technical discipline are described broadly in chronological order.在每個技術學科里的活動按時間先后排列的順序大致作了介紹。：There then follows assembly of a marketing application dossier for subsequent review by country regulatory authorities.翻譯 ：然后附述一個由國家監(jiān)管當局隨后審查的上市申請檔案的匯編。31原句:‘Optimun’ here may mean a bination of several factors, for example, most efficient, cheapest safe, or that producing minimal waste.翻譯:這里“最佳” 可能意味著多種因素的組合，例如，最有效，最便宜的安全，或產生最少的廢物。ofnecessarydevelopmentpuritysubstance譯：分析方法的開發(fā)和驗證對于支持工藝開發(fā)和保證原料藥的純度是必要的。3before transferring to a pilot plant, extensive evaluation and testing of the chemical synthesis is undertake to ensure that any changes and hazards are minimized.譯：在轉入中試工廠前，需要對化學合成進行廣泛的評估和測試，以確保任何的改變和危害降至最低。43 There are a vast array of possible dosage forms ranging from transderal patches to inhalers to intranasal medicines有大量從透皮貼片到滴鼻藥的可能劑型。dosagetabletsliquids,topicalinjectables.較常見的劑型包括口服片劑或膠囊、口服液、局部藥膏或霜劑、和注射劑。binationotherit50、One of the most important is that of adequate stability 最重要的標準之一是有足夠的穩(wěn)定性。 in development the shelflife may be limited to several months.在開發(fā)的早期，其保質期可能僅限于數(shù)月。beitcoverdrugofordr