ArticleThe AAPS journal2020
Physiologically Based Pharmacokinetic Modeling and Simulation of Sunitinib in Pediatrics.
Article in The AAPS journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.
- Factors Affecting Pharmacokinetics of Sunitinib and Its Metabolite, SU12662: A Systematic Review of Population Pharmacokinetic Studies.European journal of drug metabolism and pharmacokinetics · 2025Pooled it
- Accelerating Pediatric Oncology Drug Development: Advances in Clinical Pharmacology, Trial Design, Non-Clinical Evidence, and Regulatory Science.Journal of clinical pharmacology · 2026Review
- Physiologically-based pharmacokinetic models versus allometric scaling for prediction of tyrosine-kinase inhibitor exposure from adults to children.Cancer chemotherapy and pharmacology · 2024Article
- Application of physiologically based pharmacokinetics modeling in the research of small-molecule targeted anti-cancer drugs.Cancer chemotherapy and pharmacology · 2023Review
- Model-informed approach to support pediatric dosing for the pan-PI3K inhibitor copanlisib in children and adolescents with relapsed/refractory solid tumors.Clinical and translational science · 2023Article
- Pediatric oncology drug development and dosage optimization.Frontiers in oncology · 2023Review
- In-Depth Analysis of Physiologically Based Pharmacokinetic (PBPK) Modeling Utilization in Different Application Fields Using Text Mining Tools.Pharmaceutics · 2022Review
- Review
- Physiologically Based Pharmacokinetic Models Are Effective Support for Pediatric Drug Development.AAPS PharmSciTech · 2021Review
- Assessment of the Utility of Physiologically-based Pharmacokinetic Model for prediction of Pharmacokinetics in Chinese and Japanese Populations.International journal of medical sciences · 2021Article
- Bottom-Up Physiologically Based Oral Absorption Modeling of Free Weak Base Drugs.Pharmaceutics · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Using physiologically based pharmacokinetic (PBPK) modeling and simulations, this study estimated the exposure of sunitinib and its active metabolite SU012662 in pediatric patients. A PBPK simulator, SimCYP, was used to develop and validate the pharmacokinetic models. Model development employed a combined "bottom-up" and "top-down" approach to fully utilize the available in vitro or in silico experimental data and in vivo observed clinical data. First, the PBPK model for sunitinib was established, then the cytochrome P450 3A4-mediated metabolism of sunitinib was used as the input for SU012662. PBPK models were validated using pharmacokinetics of sunitinib and SU012662 from one study in adult patients with solid tumors and three clinical trials in pediatric patients with solid or gastrointestinal stromal tumors. The models were further used to predict the exposure of sunitinib and SU012662 by pediatric age groups. The PBPK models for sunitinib and SU012662 developed based on pharmacokinetic characteristics in adults successfully predicted the observed in vivo pharmacokinetics of sunitinib and SU012662 in both adults and pediatric patients. Based on the SimCYP model predictions, a daily dose of 20 mg/m
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.