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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 | Source: | 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. | Keywords: | Controlled release; Convolution; Dissolution curve; IVIVC; One-stage model fitting;controlled release; convolution; dissolution curve; IVIVC; one-stage model | Document URI: | http://hdl.handle.net/1942/9002 | ISSN: | 1054-3406 | e-ISSN: | 1520-5711 | DOI: | 10.1080/10543400802369061 | ISI #: | 000260764800011 | Rights: | Copyright © Taylor & Francis Group, LLC | Category: | A1 | Type: | Journal Contribution | Validations: | ecoom 2009 |
Appears in Collections: | Research publications |
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File | Description | Size | Format | |
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GeertMolenberghs15.pdf | Peer-reviewed author version | 192.6 kB | Adobe PDF | View/Open |
jacobs2008.pdf Restricted Access | Published version | 403.14 kB | Adobe PDF | View/Open Request a copy |
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