Abbott, Rockville, Maryland, USA.
Clin Pharmacol Ther. 2010 Aug;88(2):158-61. doi: 10.1038/clpt.2010.141.
Traditionally, medical and biostatistical experts have played a central role in ensuring validity of pharmaceutical testing. The science of pharmacometrics provides powerful approaches for supporting important drug development and regulatory decisions. Numerous case studies published by academic, industry, and US Food and Drug Administration scientists attest to the significant contribution of pharmacometrics to decision making. The economic and public health benefits of applying this discipline to clinical trials far outweigh the cost associated with its implementation. The purpose of the American Society for Clinical Pharmacology and Therapeutics (ASCPT) Task Force is to build on the momentum and accelerate dissemination of its impact and adoption into drug development. We describe briefly the contributions of pharmacometrics and the specific goals of the Task Force.
传统上，医学和生物统计专家在确保药物测试的有效性方面发挥了核心作用。药物计量学为支持重要的药物开发和监管决策提供了强大的方法。学术、工业界和美国食品和药物管理局科学家发表的许多案例研究证明了药物计量学对决策的重大贡献。将这一学科应用于临床试验带来的经济效益和公共卫生效益远远超过了实施这一学科所带来的成本。美国临床药理学与治疗学学会（ASCPT）工作组的目的是利用这一势头，加速其影响的传播和在药物开发中的采用。我们简要描述了药物计量学的贡献和工作组的具体目标。
