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药效学研究在新型抗菌药物评估与研发中的作用。

The role of pharmacodynamic research in the assessment and development of new antibacterial drugs.

作者信息

Lister Philip D

机构信息

Center for Research in Anti-Infectives and Biotechnology, Department of Medical Microbiology and Immunology, Creighton University School of Medicine, 2500 California Plaza, Omaha, NE 68178, USA.

出版信息

Biochem Pharmacol. 2006 Mar 30;71(7):1057-65. doi: 10.1016/j.bcp.2005.10.038.

Abstract

Antibacterial resistance continues to increase world wide, with some bacterial pathogens exhibiting resistance to virtually all available drugs. As the plague of antibacterial resistance continues to grow and create serious therapeutic problems, it is essential that the development of new antibacterial agents continue. Pharmacodynamic research plays an important role in the development of new antibacterial agents, as pharmacodynamic data can help define the clinical potential of a new drug and identify the strengths and weaknesses in comparison to other drugs already on the market. Furthermore, pharmacodynamic experiments can help focus the clinical phases of drug development by providing key information on the pharmacodynamic parameters that influence efficacy and the pharmacodynamic targets that should be achieved to optimize clinical success. Characterization of these pharmacodynamic properties for a new drug in development can help direct the design of the best dose and dosing strategy for clinical trials. This review will focus on the tools, methods, and strategies used to characterize the pharmacodynamics of antibacterial agents and aide in their development for clinical use.

摘要

全球范围内,细菌耐药性持续上升,一些细菌病原体几乎对所有现有药物都表现出耐药性。随着细菌耐药性这一难题不断加剧并引发严重的治疗问题,持续研发新型抗菌药物至关重要。药效学研究在新型抗菌药物研发中发挥着重要作用,因为药效学数据有助于确定新药的临床潜力,并与市场上已有的其他药物相比,找出其优势与不足。此外,药效学实验可通过提供有关影响疗效的药效学参数以及为优化临床疗效应实现的药效学靶点的关键信息,帮助聚焦药物研发的临床阶段。对正在研发的新药的这些药效学特性进行表征,有助于指导临床试验最佳剂量和给药策略的设计。本综述将重点关注用于表征抗菌药物药效学并助力其临床应用研发的工具、方法和策略。

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