催交
药物开发
药品
药物遗传学
临床试验
人口
医学
风险分析(工程)
药理学
生物
工程类
遗传学
环境卫生
内科学
基因
基因型
系统工程
作者
Iris Rajman,Masashi Hirano,Wataru Honma,Sylvia Zhao
标识
DOI:10.1016/j.drudis.2019.12.013
摘要
Some Asian regulators currently require Phase I data in Asians before joining global Phase II/III trials. Here, we discuss inherent limitations of Phase I ethnic sensitivity studies (ESS) to identify potential interethnic differences. We review recent new drug applications (NDAs) for Japan and China to critically assess the value of separate ESSs in Asian populations. Given that the observed value of ESS was limited, we propose a new global drug development paradigm: if relevant safety, pharmacokinetic (PK), and pharmacogenetic (PG) data are available from the original Phase I study population, it might be possible to extrapolate those data to Asian populations for their inclusion in Phase II/III trials, without an ESS. This could help to streamline drug development in Asia while still addressing regulatory requirements.
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