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一个PKPD案例研究:在瘤学小鼠模型中实现AZD5991的临床相关暴露

Michael J White¹, Letitia Cheatham², Shenghua Wen²

¹AstraZeneca Research and Development Boston: AstraZeneca R&D Boston, Waltham, Massachusetts, USA. michael.white1@astrazeneca.com.

The AAPS journal

|June 28, 2023

概括

准确地建模临床前药物暴露对于有效的翻译至关重要. 这项研究开发了一种数学模型,以匹配小鼠中的人类药物暴露,改善Mcl-1抑制剂的疗效预测.

科学领域:

药理学和毒理学药理学和毒理学
翻译医学是一种翻译医学.
数学建模的数学建模

背景情况:

将临床前药物数据转化为人类疗效是一个挑战.
在动物模型中精确回顾人类药理动力学 (PK) 是必不可少的.
Mcl-1 抑制剂 AZD5991 需要精确的临床前暴露建模.

研究的目的:

开发一种数学模型,以基于PK配置文件来预测药物疗效.
建立方法,在小鼠中实现人类同等的药物暴露.
调查AZD5991.1.的暴露与疗效之间的关系.

主要方法:

开发一种精细的数学模型,将药物度与疗效联系起来.
探索各种管理路径以达到目标暴露.
使用血管接入按 (VAB) 技术在小鼠中进行静脉输液.

主要成果:

通过VAB技术进行静脉输液,成功地在小鼠中复制了AZD5991临床暴露.
不同的PK配置文件导致了目标参与度和疗效的显著差异.
开发的模型表明了PK指标和疗效结果之间的关系.

结论:

准确的临床前药物动力学建模对于预测临床疗效至关重要.
在小鼠中达到与人类相当的药物暴露,提高了翻译有效性.
这种方法提高了新疗法疗效预测的可靠性.

关键词:

AZD5991 一个很好的机会.这是PKPD的PKPD.临床翻译临床翻译在临床前建模.翻译 PK PK 的翻译血管接入按血管接入按

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