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相关概念视频

Mechanistic Models: Compartment Models in Individual and Population Analysis01:23

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Mechanistic models are utilized in individual analysis using single-source data, but imperfections arise due to data collection errors, preventing perfect prediction of observed data. The mathematical equation involves known values (Xi), observed concentrations (Ci), measurement errors (εi), model parameters (ϕj), and the related function (ƒi) for i number of values. Different least-squares metrics quantify differences between predicted and observed values. The ordinary least...
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The rate of a reaction is affected by the concentrations of reactants. Rate laws (differential rate laws) or rate equations are mathematical expressions describing the relationship between the rate of a chemical reaction and the concentration of its reactants.
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Quantitative analysis is a technique for measuring the amount of specific constituents in a sample. When the sample's composition is unknown, qualitative analysis is performed first to identify its components, which ensures that the correct substances are measured during the quantitative phase.
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When one or more data points appear far from the rest of the data, there is a need to determine whether they are outliers and whether they should be eliminated from the data set to ensure an accurate representation of the measured value. In many cases, outliers arise from gross errors (or human errors) and do not accurately reflect the underlying phenomenon. In some cases, however, these apparent outliers reflect true phenomenological differences. In these cases, we can use statistical methods...
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A system at equilibrium is in a state of dynamic balance, with forward and reverse reactions taking place at equal rates. If an equilibrium system is subjected to a change in conditions that affects these reaction rates differently (a stress), then the rates are no longer equal and the system is not at equilibrium. The system will subsequently experience a net reaction in the direction of a greater rate (a shift) that will re-establish the equilibrium. This phenomenon is summarized by Le...
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A calibration curve is a plot of the instrument's response against a series of known concentrations of a substance. This curve is used to set the instrument response levels, using the substance and its concentrations as standards. Alternatively, or additionally, an equation is fitted to the calibration curve plot and subsequently used to calculate the unknown concentrations of other samples reliably.
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在度-QT分析中超越线性模型.

Géraldine Cellière1, Andreas Krause2, Guillaume Bonnefois2

  • 1Clinical Pharmacology and Pharmacometrics, Simulations Plus, Inc., PO Box 12317, Research Triangle Park, NC, 27709, USA. geraldine.celliere@simulations-plus.com.

Journal of pharmacokinetics and pharmacodynamics
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PubMed
概括
此摘要是机器生成的。

本研究引入了用于药物度-QT间隔延长评估的先进的药物测量模型. 这些模型提供了一种比标准线性回归更强大,更可靠的方法来评估药物安全性.

关键词:
度-QT 时间这是一种歇斯底里症.人口PK/PD的人口在 QT 间隔.TQQTT 这就是TQT.

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科学领域:

  • 制药指标 (Pharmacometrics) 是一个指标.
  • 心血管药理学心血管药理学
  • 药物安全评估 药物安全评估

背景情况:

  • 评估药物诱导的QT责任的标准白皮书回归模型依赖于特定假设,如线性和即时药物效应.
  • 替代度-QT模型经常被忽视,除非标准模型的假设明显违反.
  • 需要更强大,更灵活的建模方法来准确评估QT延长风险.

研究的目的:

  • 在药量测量框架内引入和评估标准度-QT建模方法的扩展.
  • 为了使各种度-QTc关系的使用超出简单的线性,包括非线性和间接响应模型.
  • 为了便于使用既有药量计工具进行定量模型比较和评估歇斯底里症.

主要方法:

  • 制定了一种线性药物效应模型,将治疗,时间和基线作为共变量.
  • 扩展模型以适应度-QTc关系的日志线性,Emax和间接效应模型.
  • 利用药量测量评估工具,包括视觉预测检查和贝叶斯信息标准用于模型比较.
  • 应用了这种方法来分析以前涉及多种化合物的QTc研究数据.

主要成果:

  • 与基线 (ΔΔQTc) 相比,安慰剂校正的QT变化非线性混合效应模型表现出高于标准线性模型的性能.
  • 候选模型的定量比较,包括非线性和歇斯底里模型,为选择最合适的模型提供了可靠的方法.
  • 拟议的半自动化方法准确地确定了在特定药物度下QT延长的程度.

结论:

  • 先进的药量计模型,包括非线性和歇斯底里模型,提供了比传统的线性模型更强大和可靠的药物诱导的QT延长评估.
  • 使用药量计工具进行定量模型比较,提高了QT责任评估的准确性和稳定性.
  • 这种方法可以更全面地了解度-QT关系和潜在的时间延迟 (hysteresis).