Liu Jen-pei, Chow Shein-Chung
Department of Statistics, National Cheng-Kung University, Tainan, Taiwan.
J Biopharm Stat. 2002 Aug;12(3):359-67. doi: 10.1081/bip-120014564.
Global development of pharmaceutical products has become the key to the success of any pharmaceutical sponsors. It is therefore crucial to address the efficacy and safety variations of a new test pharmaceutical product among different geographic regions due to ethnic factors. Recently, geotherapeutics has attracted much attention from sponsors as well as regulatory authorities from different geographic regions. To address this issue, the International Conference on Harmonization (ICH) has published a guideline entitled "Ethnic Factors in the Acceptability of Foreign Clinical Data," which is known as ICH E5 guideline. The ICH E5 guideline provides a general framework for evaluation of the impact of ethnic factors on the efficacy, safety, dosage, and dose regimen. We provide an overview of ICH E5 guideline including ethnic sensitivity, necessity of bridging studies, types of bridging studies, and assessment of similarity between regions based on bridging evidence. In addition, challenges on the establishment of regulatory requirements, the assessment of bridging evidence, and design and analysis of bridging studies are addressed.
药品的全球研发已成为任何制药赞助商成功的关键。因此，解决由于种族因素导致的新型受试药品在不同地理区域间的疗效和安全性差异至关重要。最近，地域治疗学引起了不同地理区域的赞助商和监管机构的广泛关注。为解决这一问题，国际协调会议（ICH）发布了一项名为《国外临床数据可接受性中的种族因素》的指南，即ICH E5指南。ICH E5指南为评估种族因素对疗效、安全性、剂量和给药方案的影响提供了一个总体框架。我们概述了ICH E5指南，包括种族敏感性、桥接研究的必要性、桥接研究的类型以及基于桥接证据的区域间相似性评估。此外，还讨论了建立监管要求、评估桥接证据以及桥接研究的设计和分析方面的挑战。
