ArticleThe AAPS journal2025
Development of a Multi-Purpose Comprehensive Physiologically Based Pharmacokinetic Model for Crizotinib: An Example Application in Bioequivalence Assessment between Oral Solution and Granules in Pediatric Subjects.
Article in The AAPS journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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Who cites it
2 citing papers in PubMed.
- Quantitative Estimation of Clinical Intrasubject Variability of a Pharmacokinetic Parameter.The AAPS journal · 2026Article
- Commentary and Review on Prospective Prediction of Bioequivalence of Oral Dosage Forms using Compendial Dissolution Testing and PBPK Modeling.The AAPS journal · 2025Review
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Authors and funding
8 authors.
Funding
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Abstract
Crizotinib exhibits a complex drug-drug interaction as it is a CYP3A4 substrate and acts as both a time-dependent inhibitor and inducer of the enzyme. Absorption of crizotinib is also complex as it exhibits a prolonged absorption phase. The primary objective of this research was to develop a comprehensive physiologically based pharmacokinetic (PBPK) model to mechanistically describe both metabolism and absorption of crizotinib. The established crizotinib adult PBPK model was extrapolated to pediatric population using the modified CYP3A4 ontogeny profile to evaluate the pharmacokinetic (PK) profile after a single dose administration of crizotinib under the fasted condition in pediatric population age between 1 to 6 years old. The model was further applied to conduct virtual bioequivalence (BE) trials including clinically observed intra-subject coefficient of variation (ICV%) in both adult and pediatric populations. In adult subjects, the estimated geometric mean ratio for AUC
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