Bjornsson Thorir D, Wagner John A, Donahue Stephen R, Harper Dawn, Karim Aziz, Khouri Marlene S, Murphy William R, Roman Kristin, Schneck Dennis, Sonnichsen Daryl S, Stalker Dennis J, Wise Stephen D, Dombey Stuart, Loew Caroline
Wyeth Research, 500 Arcola Road, Collegeville, PA 19426, USA.
J Clin Pharmacol. 2003 Sep;43(9):943-67. doi: 10.1177/0091270003256065.
The International Conference on Harmonization (ICH) E5 guidelines were developed to provide a general framework for evaluating the potential impact of ethnic factors on the acceptability of foreign clinical data, with the underlying objective to facilitate global drug development and registration. It is well recognized that all drugs exhibit significant inter-subject variability in pharmacokinetics and pharmacologic response and that such differences vary considerably among individual drugs and depend on a variety of factors. One such potential factor involves ethnicity. The objective of the present work was to perform an extensive review of the world literature on ethnic differences in drug disposition and responsiveness to determine their general significance in relation to drug development and registration. A few examples of suspected ethnic differences in pharmacokinetics or pharmacodynamics were identified. The available literature, however, was found to be heterologous, including a variety of study designs and research methodologies, and most of the publications were on drugs that were approved a long time ago.
国际协调会议（ICH）的E5指南旨在为评估种族因素对国外临床数据可接受性的潜在影响提供一个总体框架，其根本目标是促进全球药物开发和注册。众所周知，所有药物在药代动力学和药理反应方面都表现出显著的个体间差异，而且这些差异在不同药物之间有很大不同，并取决于多种因素。其中一个潜在因素涉及种族。本研究的目的是广泛回顾世界文献中关于药物处置和反应性方面的种族差异，以确定它们在药物开发和注册方面的总体意义。已确定了一些药代动力学或药效学方面疑似种族差异的例子。然而，发现现有文献存在异质性，包括各种研究设计和研究方法，而且大多数出版物涉及的是很久以前就已获批的药物。
