Population pharmacokinetics - III: Design, analysis, and application of population pharmacokinetic studies
Population pharmacokinetics - III: Design, analysis, and application of population pharmacokinetic studies
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DOI：
10.1345/aph.1e260
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发表时间：
2004-12-01
影响因子：
2.9
通讯作者：
Lane, JR
中科院分区：
文献类型：
--
作者：
Ette, EI;Williams, PJ;Lane, JR
目的：提出群体药代动力学（PPK）研究的设计和分析框架，并讨论已开发的PPK模型的应用。方法：从MEDLINE检索文献（1979- 2003年12月）和综述文章和书籍的书目评价中检索有关PPK的信息。这些信息与经验相结合，用于解释PPK研究的设计和分析。此外，还包括一些示例来演示PPK的有用性。综合：必须对PPK研究的设计和分析（即PPK模型的开发）进行大量的思考。模型有两种主要类型——描述性和预测性——应用于这些模型的过程必然是不同的。提出了一种保证模型适用性的方法。结论：PPK模型实用性强，应用广泛。它们与单受试者药代动力学模型非常不同，因此需要不同的模型估计方法。
Objective: To present a framework within which population pharmacokinetic (PPK) studies should be designed and analyzed and discuss the application of developed PPK models.Methods: Information on PPK was retrieved from a MEDLINE search (1979-December 2003) of the literature and a bibliographic evaluation of review articles and books. This information is used in conjunction with experience to explain the design and analysis of PPK studies. Also, examples are included to demonstrate the usefulness of PPK.Synthesis: A great deal of thought must be given to the design and analysis of PPK studies (ie, development of PPK models). Models are of 2 primary types-descriptive and predictive-and the process applied to these models is necessarily different. An approach that ensures model applicability is presented.Conclusions: PPK models have great utility, and the applications are many. They are very different from single-subject pharmacokinetic models and therefore require different approaches to model estimation.