A physiologically based biopharmaceutics modeling (PBBM) framework for characterizing formulation-dependent food effects: Paving the road towards fed state virtual BE studies for itraconazole amorphous solid dispersions

This study leverages physiologically based biopharmaceutics modeling (PBBM) to predict the clinical performance of two itraconazole (ITRA) amorphous solid dispersions (ASDs), Sempera® and Tolsura®, under fasted and fed state conditions, exploring the potential of PBBM in predicting formulation-speci...

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Bibliographic Details
Published in:	European journal of pharmaceutical sciences Vol. 209; p. 107047
Main Authors:	Rudolph, Niklas, Charbe, Nitin, Plano, David, Shoyaib, Abdullah Al, Pal, Arindom, Boyce, Heather, Zhao, Liang, Wu, Fang, Polli, James, Dressman, Jennifer, Cristofoletti, Rodrigo
Format:	Journal Article
Language:	English
Published:	Netherlands Elsevier B.V 01.06.2025
Subjects:	Administration, Oral Adult Antifungal Agents - administration & dosage Antifungal Agents - chemistry Antifungal Agents - pharmacokinetics Between-subject variability Biopharmaceutics - methods Chemistry, Pharmaceutical Drug Liberation Fasting Food effect Food-Drug Interactions Generic drug development Humans Hypochlorhydria In vitro biopharmaceutics assessment Intestinal Absorption Itraconazole Itraconazole - administration & dosage Itraconazole - chemistry Itraconazole - pharmacokinetics Male Models, Biological PBBM Regulatory decision making Sempera Solubility Tolsura In vitro biopharmaceutics assessment Food effect Hypochlorhydria Regulatory decision making PBBM Sempera Between-subject variability Itraconazole Tolsura Generic drug development
ISSN:	0928-0987, 1879-0720, 1879-0720
Online Access:	Get full text
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