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中国临床药理学与治疗学 ›› 2008, Vol. 13 ›› Issue (5): 481-493.

• 专论 •    下一篇

定量药理学:一个促进药物开发及转换型研究严谨思考的多学科领域

Jeffrey S Barrett1, PhD, FCP, Michael J Fossler2, PharmD, PhD, FCP, K. David Cadieu3, BS, Marc R Gastonguay4, PhD, 编译:沈杰5, 谢海棠5, 审校:孙瑞元5   

  1. 1L aboratory for Applied PK PD, Clinical Pharmacology &Therapeutics Division, the Children's Hospital of Philadelphia, Pediatrics Department, School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA;
    2Clinical Pharmacokinetics, Modeling and Simulation, GlaxoSmithKline, King of Prussia, Pennsylvania 19406, USA;
    3KDC Group, Inc., New Jersey, NJ 08648, USA;
    4Metrum Institute, Connecticut, USA;
    5皖南医学院弋矶山医院药物临床评价中心, 芜湖241001, 安徽
  • 收稿日期:2008-04-15 修回日期:2008-06-01 出版日期:2008-05-26 发布日期:2020-11-09
  • 作者简介:Jeffrey S. Barrett, PhD, FCP, Laboratory for Applied PK PD, Clinical Pharmacology &Therapeuti cs Division, The Children's Hospitol of Philadelphia, The University of Pennsylvania Medical School, Pediatrics Department. Tel:267-426-5479 E-mail:barrettj@email.chop. edu

Pharmacometrics, a multidisciplinary field to facilitate critical thinking in drug development and translational research settings

Jeffrey S Barrett1, PhD, FCP, Michael J Fossler2, PharmD, PhD, FCP, K. David Cadieu3, BS, Marc R Gastonguay4, PhD   

  1. 1Laboratory for Applied PK/PD, Clinical Pharmacology &Therapeutics Division, The Children's Hospital of Philadelphia;Pediatrics Department, School of Medicine, University of Pennsylvania;
    2Clinical Pharmacokinetics, Modeling and Simulation, GlaxoSmithKline, King of Prussia, Pennsylvania;
    3KDC Group, Inc., New Jersey;
    4Metrum Institute, Connecticut
  • Received:2008-04-15 Revised:2008-06-01 Online:2008-05-26 Published:2020-11-09

摘要: 尽管从事定量药理学研究的科学工作者一再强调将定量分析的原则应用于促进新药研发的决策, 定量药理学的发展还是超过了上述领域。普通研究和决策领域总是期望着常规和传统的研究范例发生进步, 当与定量药理学相关的领域自身在发展并与其交互作用时, 自然便产生对临床药理学的协同作用。创新性和可塑性训练计划和策略均是将来临床研究工作中必不可少的要素。掌握定量药理学领域的知识成为对药理科学家的要求, 具有定量药理学背景的人员可望获得更高的薪水。目前定量药理学相关培训计划, 教学资料, 及学术权威均比较贫乏, 学生们可以从企业化、调控性的背景的教师等多种机构的教职员那获得指导, 此外也可以通过在线课程, 可视化教学进修课程, 与他们的导师保持联系。对课程和学位的管理可以采取灵活的态度, 这样可在短期内培养更多的定量药理学工作者。

关键词: 定量药理学, 关键路径, 国立卫生研究院(NIH)路线图, 教育, 临床药理学(Pharmacometrics)

Abstract: Pharmacometrics has evolved beyond quantitative analysis methods used to facilitate decision making in drug development although the application of the discipline in this arena continues to represent the primary emphasis of scientists calling themselves pharmacometricians. While related fields populate and interface with pharmacometrics, there is a natural synergy with Clinical Pharmacology due to common areas of research and the decision making expectation with respect to evolving conventional and translational research paradigms.Innovative and adaptable training programs and resources are essential in this regard as both disciplines promise to be key elements of the clinical research workplace of the future. The demand for scientists with pharmacometrics skills has risen substantially. Likewise, the salary garnered by those with these skills appears to be surpassing their counterparts without such background. Given the paucity of existing training programs, available training materials and academic champions, a virtual faculty and on-line curriculum would allow students to matriculate into one of several programs associated with their advisor but taking instruction from faculty at multiple institutions including instructors in both industrial and regulatory settings. Flexibility in both the curriculum and the governance of the degree would provide the greatest hope of addressing the short supply of trained pharmacometricians.

Key words: pharmacometrics, critical path, NIH roadmap, education, clinical pharmacology