１引言本指南旨在通过介绍一个评估人种因素对药物作用，即在特定剂量和给药方案时药物疗效和安全性的框架，以利于ＩＣＨ地区（见名词解释，附件１）的药品注册。指南涉及管理和开发策略，将允许充分评价人种因素的影响，尽量减少重复临床研究和加速将药品用于病人。本文件中 1 Introduction The purpose of this guideline is to facilitate the registration of medicines in the ICH area (see Glossary, Annex 1) by introducing a framework for assessing the effect of race on drugs, ie, the efficacy and safety of medicines at specific dosages and dosing schedules. The guideline involves management and development strategies that will allow for a full assessment of the effects of ethnic factors, minimizing duplication of clinical research and accelerating the use of drugs in patients. This document