Mauger D T, Chinchilli V M
Department of Health Evaluation Sciences, Pennsylvania State University College of Medicine, Hershey 17033, USA.
J Biopharm Stat. 1997 Nov;7(4):565-78. doi: 10.1080/10543409708835207.
It is of interest to predict the in vivo behavior of an oral extended-release drug product based on its in vitro dissolution profile. In some cases a suitable convolution-based prediction model can be found. We present a methodology for developing statistical models of in vitro-in vivo relationships under the framework of the mixed-effects nonlinear model and discuss methods for assessing the validity and strength of the relationship. These methods are illustrated and contrasted with a level A in vitro-in vivo correlation using data from a study involving four different formulations of an oral extended-release drug product.
基于口服缓释药物产品的体外溶出曲线来预测其体内行为是很有意义的。在某些情况下，可以找到合适的基于卷积的预测模型。我们提出了一种在混合效应非线性模型框架下开发体外-体内关系统计模型的方法，并讨论了评估这种关系的有效性和强度的方法。使用来自一项涉及口服缓释药物产品四种不同制剂的研究数据，对这些方法进行了说明，并与A级体外-体内相关性进行了对比。
