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论文编号：	7404
作者编号：	2220100830
上传时间：	2015/6/9 14:38:24
中文题目：	天津药物研究院新药项目知非沙班的研发风险管理研究
英文题目：	The Study of R&D Management of New Drug Project Zifaxaban in TIPR
指导老师：	周建
中文关键字：	项目风险管理；新药研发；知非沙班；天津药物研究院
英文关键字：	new drug research and development；risk management of project； Zifaxaban;TIPR
中文摘要：	医药产业因关乎人类健康属于高科技含量的朝阳产业，在我国属于战略性新兴产业。高投入、长周期、高风险是新药研发的特点，也导致新药研发这项庞大的系统工程具有巨大的风险，在研发过程中，必须采取一切可能的措施来进行风险控制。 本文选择天津药物研究院作为研究背景，选择该院研制的仿创新药知非沙班作为具体研究对象，系统分析了新药研发过程及新药特征，结合项目管理理论及该院管理实践，重点研究了知非沙班临床前研究阶段的决策风险和技术风险。本文首先阐明了影响新药研发成功与否的三大因素：市场饱和度、疗效、安全性，这三大因素决定了项目的研发走向和开发顺序。在新药研发的决策环节，大量采用专家法来识别项目风险，而识别项目的技术风险则结合了专家法、项目流程图法、头脑风暴法等。 知非沙班是新型Xa因子抑制剂，在其研发过程中，结合工作流程制定了风险控制的流程和节点。在长达5年的临床前研究过程中，涉及药学、药理学、药物分析学、药剂学等多学科的参与和协调，项目流程图法所涉及的节点控制标准，是被实践检验、较为行之有效的风险控制手段，辅以知识产权策略、专家库建设与管理、模型筛选等管理工具，保障了知非沙班既定的满足市场需求、较已有上市新药更有效更安全的研发目标。
英文摘要：	The pharmaceutical industry is an increasing high-tech industry due to the concerns of human health, and it belongs to one of the strategic emerging industries in China. The factors of high investment, long period, and high risk are the characteristics of new drug research and development, and also lead to tremendous risks to the huge project of new drug research and development. In this situation, we must take all possible measures to control the risks during the development process. This thesis chose Tianjin Institute of Pharmaceutical Research as the research background and generic drug of Zifaxaban developed by the institute as the research object. The thesis analyzed the process of drug development and the drug characteristics, and discussed the decision-making risks and technological risks of preclinical research stage of Zifaxaban, combined with the theory of project management and the management practices of the institute. The paper firstly illustrates the three factors that influence the new drug research and development, which are market saturation, efficacy, and safety. These three factors determine the trend of research and the order of project development. In the decision making process of new drug research and development, a large number of experts were used to identify the project risks. The process of the identification of technological risks combined with experts, project flowchart, and brainstorming. Zifaxaban is a new factor Xa inhibitor. During its development process, the workflow process was applied to establish the risk control process and nodes. In the process of 5-year preclinical studies, the project flow chart method and involved node control standards, which have pharmacy, pharmacology, pharmacoanalysis, pharmaceutical, and other multi-disciplinary participation and coordination, have been examined by practices as effective means of risk control. Combined with the intellectual property strategy, construction and management of expert database, and model selection and management tools, the market demand of Zifaxaban has been protected, and a more effective and safer development objective can be identified and established.
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