Anderson Brian J, Allegaert Karel, Holford Nicholas H G
Department of Anaesthesiology, University of Auckland, Auckland, New Zealand.
Eur J Pediatr. 2006 Nov;165(11):741-6. doi: 10.1007/s00431-006-0188-y. Epub 2006 Jun 29.
Population modelling using mixed-effects models provides a means to study variability in drug responses among individuals representative of those for whom the drug will be used clinically.
The advantages of these models in paediatric studies are that they can be used to analyse sparse data, sampling times are not crucial and can be fitted around clinical procedures and individuals with missing data may still be included in the analysis. The introduction of explanatory covariates explains the predictable part of the between-individual variability. Simulations using parameter estimates and their variability can be used to investigate large numbers of children--many more than is possible in studies dealing with real children--for a fraction of the cost, which is an advantage when developing clinical trials. Paediatric population modelling has expanded greatly in the past decade and is now a routine procedure during the development and investigation of drugs. Children have benefitted and will continue to benefit from this approach.
使用混合效应模型进行群体建模提供了一种手段，用于研究在临床上使用该药物的代表性个体之间药物反应的变异性。
这些模型在儿科研究中的优势在于，它们可用于分析稀疏数据，采样时间并不关键，可以围绕临床程序进行安排，并且有缺失数据的个体仍可纳入分析。引入解释性协变量可解释个体间变异性的可预测部分。使用参数估计及其变异性进行的模拟可用于以较低成本研究大量儿童——比涉及真实儿童的研究中可能的数量多得多——这在开展临床试验时是一个优势。儿科群体建模在过去十年中得到了极大的扩展，现在已成为药物研发和研究过程中的常规程序。儿童已经并将继续从这种方法中受益。
