Zhou Honghui
Pharmacokinetics, Modeling & Simulation, Clinical Pharmacology & Experimental Medicine, Centocor Research & Development, Malvern, PA 19087, USA.
J Clin Pharmacol. 2006 Nov;46(11):1268-89. doi: 10.1177/0091270006294278.
Population-based assessments of drug-drug interactions have become more common since the introduction and acceptance of the population pharmacokinetic approach. Unlike traditional methods, population-based studies provide clinically relevant results that can be applied directly to a target patient population. Furthermore, population-based studies do not demand the traditional requirements of intensive pharmacokinetic sampling, rigorous inpatient stays, or stringent assessment schedules. As such, the population-based approach can effectively be used to confirm known drug-drug interactions and further characterize anticipated interactions. A prospectively designed analysis can also reveal drug-drug interactions that might otherwise have gone undetected with traditional methods. Ultimately, these results could help to alleviate clinicians' concerns about using widely marketed drugs in combination therapies and also reduce patients' risk of experiencing unacceptable side effects. This article intends to provide a balanced overview of the population-based approach and its merits, drawbacks, and potential utility in the assessment of drug-drug interactions during clinical drug development.
自从群体药代动力学方法被引入并得到认可以来，基于群体的药物相互作用评估变得更加普遍。与传统方法不同，基于群体的研究提供了可直接应用于目标患者群体的临床相关结果。此外，基于群体的研究并不需要传统方法所要求的密集药代动力学采样、严格的住院时间或严格的评估时间表。因此，基于群体的方法可有效地用于确认已知的药物相互作用，并进一步描述预期的相互作用。前瞻性设计的分析还可以揭示传统方法可能未检测到的药物相互作用。最终，这些结果有助于减轻临床医生对联合使用广泛上市药物的担忧，并降低患者出现不可接受副作用的风险。本文旨在全面概述基于群体的方法及其在临床药物开发过程中评估药物相互作用的优点、缺点和潜在用途。
