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Can PBPK Modeling Streamline Food Effect Assessments?
Author(s) -
Kesisoglou Filippos
Publication year - 2020
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1002/jcph.1678
Subject(s) - physiologically based pharmacokinetic modelling , pharmacokinetics , drug , biopharmaceutics , pharmacology , biopharmaceutics classification system , food and drug administration , clinical pharmacology , workflow , biochemical engineering , medicine , computer science , chemistry , engineering , pharmacognosy , biochemistry , database , biological activity , in vitro
Physiologically based pharmacokinetic (PBPK) modeling is routinely used to study drug‐drug interactions, replace some dedicated clinical studies, and inform product labeling. More recently, there has been increased application of PBPK models in the oral absorption field around drug product quality. Given the success of the models to characterize absorption of several orally administered drug products, a question arises whether PBPK could be used in a clinical setting to model food‐drug interactions and thus streamline food effect assessments. Multiple publications have reported food effect predictions and comparisons with clinical data, primarily focusing on 2 food effect mechanisms: slowing down of gastric emptying and luminal solubilization by bile salts. Based on the available literature, this commentary proposes a workflow that PBPK model could be used to streamline food effect assessment during clinical development for different Biopharmaceutics Classification System classes.