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图库西的数值验证,这是一个有前途的贝叶斯适应工具,用于以模型为基础的精确剂量
Anne Ravix1, Annie E Cathignol2,3, Thierry Buclin4
1Center for Research and Innovation in Clinical Pharmaceutical Sciences, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
图库西 (Tucuxi) 是一种基于模型的精确剂量软件,可以准确预测药理动力学结果. 它的性能与NONMEM紧密相匹配,这是一个黄金标准工具,表明其可靠性用于临床使用.
科学领域:
- 药理动力学和药理动力学
- 计算生物学和生物信息学
- 临床药理学 临床药理学
背景情况:
- 模型信息精确剂量 (MIPD) 软件有助于临床决定治疗药物度.
- 准确预测药物动力学参数对于优化药物治疗至关重要.
研究的目的:
- 为了评估Tucuxi的预测准确度,一个新的MIPD软件.
- 为了比较Tucuxi的预测与NONMEM,一个被广泛接受的贝叶斯制药动力学建模工具.
主要方法:
- 开发了一组模拟各种施用途径和剂量方案的药理学模型小组.
- 创建虚拟患者群体 (n=4000),模拟稀疏和丰富的样本配置文件.
- 使用相对差异,MPE和RMSE,对度,Cmin,Cmax和AUC0-24h的Tucuxi和NONMEM预测进行了比较.
- 适用于AUC0-24h,Cmin和Cmax的生物等价性标准进行进一步比较.
主要成果:
- 图库西表现出高预测准确度,在所有模拟场景中与NONMEM预测密切匹配.
- 采样时预测度的中位数为99.8%,相对误差为<0.1%.
- 平均预测误差 (MPE) 和相对根平均平方误差 (RMSE) 是最小的 (分别为0%和0.82%).
- 所有模型都符合生物等价性标准,AUC0-24h,Cmin和Cmax的中位数为100%.
结论:
- 图库西表现出极好的预测准确度,与黄金标准NONMEM相提并论.
- 该软件的可靠性表明,在临床实践中采用该软件有很大的潜力,以指导精确剂量.
- 图库西可以有效地支持患者实现治疗度目标.
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