【摘要】 许多药物的代谢途径可被联用药物抑制或诱导,有时会引起药物药理或毒理效应的显著变化。代谢性药物-药物相互作用发生率高,临床效应显著。制药工业和管理部门已经将药物-药物相互作用的研究从临床试验阶段转移至新药开发的早期阶段。代谢性药物-药物相互作用研究分为体内外试验,合理的研究设计不仅对于评价药物的安全性和有效性具有重要意义,而且可以节约研究成本,避免不必要的资源浪费。文中从研究背景、机理等方面介绍代谢性药物-药物相互作用的研究进展,并着重介绍相关试验设计,期望对国内制药工业及科学研究有所启发。更多还原

【Abstract】 The pharmacological or toxicological efficacy of drugs can be influenced significantly when their metabolic pathway is induced or inhibited by co-administrated drugs.Metabolism-based drug-drug interactions (DDIs) have a high incidence and are important in clinical therapeutics.Studies on metabolism-based DDIs are now moved to the early stages of drug development,so that adequate assessment of its safety and effectiveness can be facilitated.These studies comprise in vitro and in vivo investigations and an appropriate design of studies is important.In many cases,negative findings from early in vitro and early clinical studies can eliminate the need for later clinical investigations.This article summarizes the background and mechanism of metabolism-based DDIs and focuses on the strategies of these studies.更多还原