Agoram Balaji M, Martin Steven W, van der Graaf Piet H
Pfizer, Department of Pharmacokinetics, Dynamics, and Metabolism (PDM), Sandwich CT13 NJ, UK.
Drug Discov Today. 2007 Dec;12(23-24):1018-24. doi: 10.1016/j.drudis.2007.10.002. Epub 2007 Nov 19.
Lack of predictability of clinical efficacy and safety is an important problem facing pharmaceutical research today. Translational PK-PD has the ability to integrate data generated from diverse test platforms during discovery and development in a mechanistic framework. Therefore, successful implementation of translational PK-PD modelling and simulation early in the development cycle could have a substantial impact on overall efficiency and success of pharmaceutical research. Three case studies are presented, which outline successful implementation of the translational PK-PD methodology in the rational development of biotherapeutics across various stages of discovery and development. Emerging developments within the field are also discussed.
临床疗效和安全性缺乏可预测性是当今药物研究面临的一个重要问题。转化性药代动力学-药效学（PK-PD）能够在一个机制框架内整合在发现和开发过程中从不同测试平台生成的数据。因此，在开发周期早期成功实施转化性PK-PD建模与模拟可能会对药物研究的整体效率和成功率产生重大影响。本文介绍了三个案例研究，概述了转化性PK-PD方法在生物治疗药物发现和开发各阶段合理开发中的成功应用。还讨论了该领域的新进展。
