一个药量计工作流程,用于解决模型不稳定性在模型使用-重复使用设置.
Stephen B Duffull1, Daniel F B Wright2,3,4, Xiao Zhu5
1Certara, Princeton, New Jersey, USA.
本教程提供了一种工作流程,以解决药理动力学 (PKPD) 模型的不稳定性,这是药物开发中的一个常见挑战. 它有助于识别和解决问题,提高模型构建效率.
科学领域:
- 药学指标 (Pharmacometrics) 是一个指标.
- 药理动力学/药理动力学 (PKPD) 是一个
- 基于模型的药物开发 (MIDD)
背景情况:
- 开发适合目的的PKPD模型对于药物开发至关重要.
- 模型稳定性问题是常见的,多因素的,阻碍了高效的模型构建.
- 现有的方法往往导致长时间的开发或过于简单的模型.
研究的目的:
- 为识别和解决PKPD模型不稳定性提供启发式工作流.
- 为了简化药物开发中的模型构建过程.
- 为使用人口分析软件的研究人员提供实际指导.
主要方法:
- 该教程介绍了一个以NONMEM分析为中心的工作流.
- 它侧重于启发式方法来诊断和修复模型的不稳定性.
- 这些概念可以推广到其他种群PK/PKPD分析软件.
主要成果:
- 拟议的工作流有助于识别模型不稳定的根本原因.
- 它有助于解决影响模型稳定的多因素问题.
- 这种方法导致更强大,更可靠的PKPD模型.
结论:
- 实施这种工作流可以显著提高PKPD模型开发的效率和成功.
- 解决模型不稳定性是强大的模型知情药物开发的关键.
- 启发式方法为常见的建模挑战提供了一个实际的解决方案.
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