Gupta Sandeep Kumar
Clinical Pharmacologist, Palam Vihar, Gurgaon, India.
Perspect Clin Res. 2011 Oct;2(4):121-3. doi: 10.4103/2229-3485.86874.
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. The ICH-E5 guideline brought great change in concept and strategy of global drug development for pharmaceutical companies. The procedures described in the ICH-E5 guideline have proved useful in the assessment of the ethnic sensitivity of a medicinal product that is to be introduced to a foreign region for registration purpose. Many companies are now developing various products based on ICH-E5 strategies and many successful cases will continuously appear within coming years.
国际人用药品注册技术协调会E5指南提供了一个总体框架，用于评估种族因素对国外临床数据可接受性的潜在影响，其根本目标是尽量减少临床数据的重复，并且还描述了将国外临床数据外推至新地区的桥接研究的要求。ICH-E5指南给制药公司的全球药物研发理念和策略带来了巨大变化。ICH-E5指南中描述的程序已证明在评估拟引入国外地区进行注册的药品的种族敏感性方面很有用。许多公司目前正在基于ICH-E5策略开发各种产品，未来几年还会不断出现许多成功案例。
