Inter-ethnic differences in drug response: Implications for drug development and complying with drug regulation

R. Shah
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引用次数: 15

Abstract

Abstract The two key components of the pharmacology of a drug—dose–concentration (pharmacokinetic) and/or concentration–response (pharmacodynamic) relationships—are often influenced by genetic variations. These account for a substantial fraction of variability in dose–response or drug response, not only between individuals, but also between different ethnic groups. The approval of ‘BiDil’ for the treatment of cardiac failure in self-identified black patients is a spectacular example of inter-ethnic differences in drug response and regulatory awareness of ethnicity of the study population. Drug development programs are increasingly undertaken globally to reduce costs, shorten timeframes, and address issues concerning global prescribing. Regulatory authorities have responded to this globalization of drug development by promulgating guidelines that recommend sponsors of new drugs to explore the role of genetic variations, and potential differences in drug response, between different ethnic populations. They may refuse to accept an application, or require bridging studies, when such differences are anticipated but not adequately addressed. These bridging studies may include (i) pharmacokinetic studies, (ii) pharmacodynamic studies, (iii) dose–response studies, and/or (iv) in extreme cases, pivotal phase III studies in order to extrapolate efficacy and/or safety data from one population to another.
药物反应的种族间差异:对药物开发和遵守药物监管的影响
药物剂量-浓度(药代动力学)和/或浓度-反应(药效学)关系的药理学两个关键组成部分经常受到遗传变异的影响。这些因素解释了剂量反应或药物反应的很大一部分差异,不仅在个体之间,而且在不同的种族群体之间。“BiDil”被批准用于治疗自我认定为黑人的心力衰竭患者,这是一个引人注目的例子,说明了药物反应和研究人群种族监管意识的种族间差异。药物开发项目越来越多地在全球范围内进行,以降低成本,缩短时间框架,并解决有关全球处方的问题。监管当局对这种药物开发的全球化作出了回应,颁布了指导方针,建议新药的赞助商探索基因变异的作用,以及不同种族人群之间药物反应的潜在差异。他们可能会拒绝接受申请,或者要求衔接学习,当这些差异是预期的,但没有充分解决。这些桥接研究可能包括(i)药代动力学研究,(ii)药效学研究,(iii)剂量反应研究,和/或(iv)在极端情况下,关键的iii期研究,以推断从一个人群到另一个人群的疗效和/或安全性数据。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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