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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/9002

Title: Combined Models for Data from In Vitro-In Vivo Correlation Experiments
Authors: Jacobs, Tom
Rossenu, Stefaan
Dunne, Adrian
Molenberghs, Geert
Straetemans, Roel
Bijnens, Luc
Issue Date: 2008
Publisher: TAYLOR & FRANCIS INC
Citation: JOURNAL OF BIOPHARMACEUTICAL STATISTICS, 18(6). p. 1197-1211
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.
Notes: [Jacobs, Tom; Molenberghs, Geert] Univ Hasselt, Interuniv Inst Biostat & Stat Bioinformat, B-3590 Diepenbeek, Belgium. [Jacobs, Tom; Molenberghs, Geert] Katholieke Univ Leuven, Louvain, Belgium. [Dunne, Adrian] Univ Coll Dublin, Sch Math Sci, Dublin 2, Ireland. [Rossenu, Stefaan; Straetemans, Roel; Bijnens, Luc] Johnson & Johnson Pharmaceut Res & Dev, Beerse, Belgium.
URI: http://hdl.handle.net/1942/9002
DOI: 10.1080/10543400802369061
ISI #: 000260764800011
ISSN: 1054-3406
Category: A1
Type: Journal Contribution
Validation: ecoom, 2009
Appears in Collections: Research publications

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