title: Combined models for data from in vitro-in vivo correlation experiments.
abstract: A method is presented to describe the in vitro-in vivo correlation (IVIVC) of an extended release drug formulation. This extended release drug product is overencapsulated with immediate release material. The heterogeneity of the capsule is modelled using a combined model of an extended release and an immediate release pharmacokinetic profile. Whereas an IVIVC is conventionally performed using a two-stage procedure, the model uses a one-stage convolution-based method. The method is applied to a Galantamine controlled release formulation, an acetylcholinesterase inhibitor for the treatment of Alzheimer's disease. The average percentage prediction error indicated a good fit of the new model.
authors.affiliation: Interuniversity Institute for Biostatistics and Statistical Bioinformatics, University Hasselt, Diepenbeek, Belgium. tom.jacobs@uhasselt.be
authors.forename: Tom
authors.initials: T
authors.lastname: Jacobs
authors.forename: Stefaan
authors.initials: S
authors.lastname: Rossenu
authors.forename: Adrian
authors.initials: A
authors.lastname: Dunne
authors.forename: Geert
authors.initials: G
authors.lastname: Molenberghs
authors.forename: Roel
authors.initials: R
authors.lastname: Straetemans
authors.forename: Luc
authors.initials: L
authors.lastname: Bijnens
mesh_terms: D002214:Capsules; D002626:Chemistry, Pharmaceutical; D002800:Cholinesterase Inhibitors / Q000737:chemistry / Q000493:pharmacokinetics*; D003692:Delayed-Action Preparations; D005702:Galantamine / Q000737:chemistry / Q000493:pharmacokinetics*; D006801:Humans; D008954:Models, Biological; D008956:Models, Chemical; D015233:Models, Statistical; D015203:Reproducibility of Results; D012995:Solubility
chemical_list: D002214:Capsules; D002800:Cholinesterase Inhibitors; D003692:Delayed-Action Preparations; D005702:Galantamine