title: In vitro-in vivo relationships for oral extended-release drug products.
abstract: 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.
authors.affiliation: Department of Health Evaluation Sciences, Pennsylvania State University College of Medicine, Hershey 17033, USA.
authors.forename: D T
authors.initials: DT
authors.lastname: Mauger
authors.forename: V M
authors.initials: VM
authors.lastname: Chinchilli
mesh_terms: D000284:Administration, Oral; D003692:Delayed-Action Preparations; D006801:Humans; D066298:In Vitro Techniques; D008432:Mathematical Computing; D008954:Models, Biological; D015233:Models, Statistical; D010599:Pharmacokinetics; D011237:Predictive Value of Tests
chemical_list: D003692:Delayed-Action Preparations