THE VALUE OF DRUG REPOSITIONING IN THE CURRENT PHARMACEUTICAL MARKET
THE VALUE OF DRUG REPOSITIONING IN THE CURRENT PHARMACEUTICAL MARKET
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DOI：
10.1358/dnp.2009.22.2.1303818
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发表时间：
2009-03-01
影响因子：
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通讯作者：
Tobinick, Edward L.
中科院分区：
文献类型：
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作者：
Tobinick, Edward L.
药物重新定位是为现有药物或生物制品开发新适应症的过程。由于尝试将新药推向市场的失败率和成本持续居高不下，人们对药物重新定位的兴趣日益浓厚。据估计，开发一种新药可能需要8亿多美元。此外，由于安全、疗效和质量方面的监管要求，开发一种新药的时间估计为10至17年。新药发现未能有效地为制药公司提供管道。合理的药物重新定位方法可能包括跨学科地关注疾病机制的阐明，使疾病途径与适当的靶向治疗药物相匹配。由于以前收集的药代动力学、毒理学和安全性数据，重新调整用途的药物或生物制品具有降低开发成本和缩短上市时间的优势。出于这些原因，重新调整用途应该是每一家广泛关注、以研究为基础的制药公司在药物发现中的主要战略。
Drug repositioning is the process of developing new indications for existing drugs or biologics. Increasing interest in drug repositioning has occurred due to sustained high failure rates and costs involved in attempts to bring new drugs to market. It has been estimated that it may cost more than USD 800 million to develop a new drug de novo. In addition, due to regulatory requirements regarding safety, efficacy and quality, the time required to develop a new drug de novo has been estimated to be 10 to 17 years. De novo drug discovery has failed to efficiently supply pharmaceutical company pipelines. A rational approach to drug repositioning may include a cross-disciplinary focus on the elucidation of the mechanisms of disease, allowing matching of disease pathways with appropriately targeted therapeutic agents. Repurposed drugs or biologics have the advantage of decreased development costs and decreased time to launch due to previously collected pharmacokinetic, toxicology and safety data. For these reasons, repurposing should be a primary strategy in drug discovery for every broadly focused, research-based pharmaceutical company.