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抗生素研发渠道:重振研发并加速药物上市

The antibiotic pipeline: reviving research and development and speeding drugs to market.

作者信息

Luepke Katherine H, Mohr John F

机构信息

a Medical Affairs Strategic Solutions, LLC , Atlanta , GA , USA.

出版信息

Expert Rev Anti Infect Ther. 2017 May;15(5):425-433. doi: 10.1080/14787210.2017.1308251. Epub 2017 Mar 29.

Abstract

The combination of growing antimicrobial resistance with a dry pipeline has resulted in infections that can no longer be treated. Specific reasons have led to companies' exit from the antibacterial space, however recent incentives are spurring interest to reinvigorate the pipeline. Areas covered: This article summarizes the available information on the discovery, developmental, and regulatory challenges in antibacterial development that have led to disinterest in the space, as well as ongoing incentives such as public-private partnerships and streamlined pathways to mend these challenges and bring new antibiotics to patients in need. Expert commentary: Clinicians should not only understand the reasons for the decline in antibiotic development that have resulted in the dry pipeline, but also the ongoing initiatives in place to build an appropriate supply. Doing so will result in greater appreciation and prudent use of these life-saving drugs when they become available.

摘要

抗菌耐药性不断增加与研发渠道枯竭相结合,导致出现了无法再治疗的感染。具体原因导致企业退出抗菌药物领域,不过近期的激励措施正激发人们重新振兴研发渠道的兴趣。涵盖领域:本文总结了抗菌药物研发中在发现、开发和监管方面的挑战,这些挑战导致该领域受到冷落,同时也介绍了诸如公私合作以及简化途径等正在实施的激励措施,以应对这些挑战并为有需要的患者带来新抗生素。专家评论:临床医生不仅应了解导致研发渠道枯竭的抗生素研发下降的原因,还应了解为建立适当供应而正在开展的举措。这样做将使人们在这些救命药物可用时,对其有更高的认识并谨慎使用。

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