一个完全自动的工具,用于开发人群的药理动力学模型
Xiaomei Chen1, Rikard Nordgren1, Stella Belin1
1Department of Pharmacy, Uppsala University, Uppsala, Sweden.
一个新的自动模型开发 (AMD) 工具简化了人口药理动力学 (PK) 模型的构建. 这个药量测量软件提供了一个更快,自动化的方法来创建复杂的PK模型用于药物开发.
科学领域:
- 制药指标 (Pharmacometrics) 是一个指标.
- 计算生物学 计算生物学
- 药物开发 药物开发
背景情况:
- 种群药动力学 (PK) 模型对于药物开发和监管评估至关重要.
- 手动开发 PK 模型是复杂的,代的,耗时的.
- 现有的方法需要大量的用户专业知识和努力.
研究的目的:
- 介绍一个全自动开发 (AMD) 人口 PK 模型的新工具.
- 在开源的Pharmpy库中实现AMD工具.
- 为了评估AMD工具的性能和效率.
主要方法:
- 该AMD工具集成了结构,个体间变化 (IIV),偶尔变化 (IOV),残余不明变化 (RUV),共变量和全量模型的模块.
- 在Pharmpy开源库中实现.
- 使用10个现实世界PK数据集进行评估,在多个序列中评估结构,IIV和RUV模型.
主要成果:
- 在整个评估序列中,AMD工具产生了普遍一致的结构模型.
- 与已发表的模型相比,最终模型显示贝叶斯信息标准 (BIC) 值较低.
- 视觉预测检查表明可比的模型质量,合理的运行时间.
结论:
- AMD工具是快速和自动化的人口PK模型构建的有希望的解决方案.
- 它有可能提高药物开发中的建模和模拟的应用.
- 该工具促进了有效的PK模型开发,帮助制药公司和监管机构.
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