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Title of Journal: Pharm Res

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Abbravation: Pharmaceutical Research

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Springer US

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DOI

10.1007/bf03008005

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ISSN

1573-904X

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A Semimechanistic Modeling Strategy for Character

Authors: Martin Bergstrand Erik Söderlind Ulf G Eriksson Werner Weitschies Mats O Karlsson
Publish Date: 2011/09/23
Volume: 29, Issue: 2, Pages: 574-584
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Abstract

To outline and test a new modeling approach for prospective predictions of absorption from newly developed modified release formulations based on in vivo studies of gastro intestinal GI transit drug release and regional absorption for the investigational drug AZD0837This work was a natural extension to the companion article “A semimechanistic model to link in vitro and in vivo drug release for modified release formulations” The drug release model governed the amount of substance released in distinct GI regions over time GI distribution of released drug substance region specific rate and extent of absorption and the influence of food intake were estimated The model was informed by magnetic marker monitoring data and data from an intubation study with local administration in colonDistinctly different absorption properties were characterized for different GI regions Bioavailability over the gutwall was estimated to be high in duodenum 70 compared to the small intestine 25 Colon was primarily characterized by a very slow rate of absorption

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