生物标记信息化药物相互作用评估在药物开发和监管决策中的实用性
Akihiro Ishiguro1, Hiroyuki Kusuhara2, Emi Kimoto3
1Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo, Japan.
临床研究中的内源生物标志物可以预测药物相互作用 (DDI) 潜力. 专家们讨论了在药物开发和监管决策中使用这些生物标志物进行早期DDI风险评估.
科学领域:
- 药理学 药理学是指药理学的学科.
- 生物标志物发现发现
- 药物开发 药物开发
背景情况:
- 在血和尿液中测量的内源生物标志物可以表明药物相互作用 (DDI) 潜力.
- 国际人用药品技术要求协调理事会 (ICH) M12指南承认用于DDI风险评估的生物标志物.
- 最近在制药和医疗器械局 (PMDA) 召开的一次会议召集了专家,讨论生物标志物的实用性.
研究的目的:
- 讨论在药物开发中使用内源生物标志物的优点和挑战.
- 促进在监管过程中早期实施基于生物标志物的DDI评估.
- 为了促进利益相关者对DDI评估中的生物标志物方法的理解.
主要方法:
- 在血和尿液内源生物标志物测量的审查.
- 讨论基于载体和酶的DDI风险评估策略.
- 在2024年临床药理学圆桌会议上建立专家共识.
主要成果:
- 生物标志物为DDI风险评估提供了一个新兴的方法.
- 专家讨论强调了生物标志物在监管决策中的潜力.
- 会议报告旨在加强对生物标志物战略的理解和采用.
结论:
- 内生生物标志物是早期DDI潜在评估的宝贵工具.
- 实施基于生物标志物的DDI评估可以简化药物开发.
- 鼓励进一步了解和采用生物标志物方法,以便在监管中使用.
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