Tobinick Edward L
Medicine at the University of California, Los Angeles, CA, USA.
Drug News Perspect. 2009 Mar;22(2):119-25. doi: 10.1358/dnp.2009.22.2.1303818.
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.
药物重新定位是指为现有药物或生物制品开发新适应症的过程。由于将新药推向市场的尝试持续面临高失败率和高成本，人们对药物重新定位的兴趣与日俱增。据估计，从头开发一种新药的成本可能超过8亿美元。此外，由于有关安全性、有效性和质量的监管要求，从头开发一种新药所需的时间估计为10至17年。从头进行药物研发未能有效地充实制药公司的产品线。药物重新定位的合理方法可能包括跨学科关注疾病机制的阐明，从而使疾病途径与适当的靶向治疗药物相匹配。由于之前已收集了药代动力学、毒理学和安全性数据，重新定位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。基于这些原因，重新定位应该是每个广泛专注于研究的制药公司药物研发的首要策略。
