It provides guidance with respect to regulatory and development strategies that will permit adequate evaluation of the influence of ethnic factors while minimizing duplication of clinical studies and supplying medicines expeditiously to patients for their benefit. This guidance should be implemented in context with the ICH guidances.

E5 Ethnic Factors/种族因素; E6 GCP/药物临床试验管理规范; E7 Clinical Trials in Geriatric Population/老人中开展的临床试验; E8 General Considerations for Clinical Trials/临床试验的一般性考虑; E9 Statistical Principles for Clinical Trials/临床试验的统计原则

ICH E5: Ethnic Factors in the Acceptability of Foreign Clinical Data (PDF - 89KB)

This document recommends a framework for evaluating the impact of ethnic factors upon a medicine's effect, i.e., its efficacy and safety at a particular dosage and dose regimen. Read together with ICH E5 (R1) Ethnic factors in the acceptability of foreign clinical data - …

The Food and Drug Administration (FDA) is publishing a guidance entitled ‘‘E5 Ethnic Factors in the Acceptability of Foreign Clinical Data.’’

The purpose of this guidance is to facilitate the registration of medicines among ICH regions* (see Glossary) by recommending a framework for evaluating the impact of ethnic factors* upon a medicine’s effect, i.e., its efficacy and safety at a particular dosage* and dose

针对临床试验的设计、实施、分析和报告各方面的一系列 ich 指南，将有助于实现完整临床数据集的概念。 这些指南包括 GCP（E6）、量-效关系评估（E4）、充分的安全性数据（E1 和 E2）、老年用药研究（E7）、研究结果的报告（E3）、一般临床试验的总体考虑（E8 ...

The ICH-E5 guideline provides a general framework for evaluating the potential impact of ethnic factors on the acceptability of foreign clinical data, with the underlying objective of minimizing duplication of clinical data, and it also describes the requirement of bridging studies for extrapolation of foreign clinical data to a new region.

2017年7月28日 · 有关临床试验的设计、实施、分析和报告方面的ich指导原则可有助于实现完整的临床资料集。 这些指导原则包括GCP（E6），量效评估（E4），安全性数据的充分性（E1和E2），老年病学研究（E7），临床研究报告（E3），临床试验的一般考虑（E8）和统计原 …

2024年2月19日 · E5_R1__Guideline-Ethnic Factors in the Acceptability of Foreign Clinical Data. 本指南主要介绍ICH中跨地区药品注册的种族数据的监管要求，是桥接试验要求的由来（因为人种有差异性，基因不同）。明确了桥接试验的定义，要求和重要性。 本文源自ICH官网，中文机翻采 …