Antimicrobial drug development - the past, the present, and the future
Antimicrobial drug development - the past, the present, and the future
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DOI：
10.1111/j.1465-0691.2004.1007.x
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发表时间：
2004-11-01
影响因子：
14.2
通讯作者：
Powers, JH
中科院分区：
文献类型：
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作者：
Powers, JH
自20世纪40年代第一批药物引入临床使用以来，抗菌素耐药性一直是一个问题。虽然在20世纪60年代发现和开发的新类别的抗菌剂提出了一系列的治疗选择，这些选择对一些严重的和危及生命的传染病现在可能更加有限。本文回顾了抗菌药物的发展历史，展示了在过去的40年里，我们在发现新药物方面所面临的挑战。抗菌药物发现和开发的现状是由这些挑战以及制药行业的经济现实所塑造的。本文还讨论了抗菌药物开发中的一些监管考虑因素，并提出了一些潜在的解决方案，以应对抗菌药物开发中固有的挑战，包括美国食品和药物管理局为简化抗菌药物的药物审查过程而采取的措施，同时保持保护和促进公众健康所需的标准。
Antimicrobial resistance has been an issue since the introduction into clinical use of the first agents in the 1940s. Although the discovery and development of new classes of antimicrobials through the 1960s presented an array of treatment options, these options for some serious and life-threatening infectious diseases may now be more limited. This paper examines the history of antimicrobial development, showing how the challenges in discovering new classes of drugs have been with us for the last 40 years. The present state of antimicrobial discovery and development is shaped by these challenges as well as by the economic realities of the pharmaceutical industry. This paper also discusses some of the regulatory considerations in antimicrobial drug development, and presents some potential solutions to the challenges inherent in antimicrobial drug development, including steps taken by the US Food and Drug Administration to streamline the drug review process for antimicrobial agents while maintaining the standards necessary to protect and promote the health of the public.