ArticleThe AAPS journal2014
Physiologically based pharmacokinetic models in the prediction of oral drug exposure over the entire pediatric age range-sotalol as a model drug.
Article in The AAPS journal, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers.
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40 citing papers in PubMed, 75 citations in OpenAlex.
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- Sotalol Dose Optimization for Fetal Tachycardia: A Pregnancy Physiologically Based Pharmacokinetic Model Study.Prenatal diagnosis · 2026Article
- Evaluation of USP 3 Apparatus to Develop Biopredictive Fasted and Fed Dissolution Methods for Extended-Release Desvenlafaxine Succinate Tablets.ACS omega · 2026Article
- The Evolution and Future Directions of PBPK Modeling in FDA Regulatory Review.Pharmaceutics · 2025Review
- A Comprehensive Physiologically Based Pharmacokinetic Framework of Ofloxacin: Predicting Disposition in Renal Impairment.Pharmaceutics · 2025Article
- Physiologically Based Pharmacokinetic Modeling and Dose Optimization of Linezolid in Pediatric Patients With Renal Impairment.Drug design, development and therapy · 2025Article
- Predicting Food-Drug Interactions between Piperine and CYP3A4 Substrate Drugs Using PBPK Modeling.International journal of molecular sciences · 2024Article
- Investigating clinical pharmacokinetics of brivaracetam by using a pharmacokinetic modeling approach.Scientific reports · 2024Article
- Physiologically Based Pharmacokinetic Model To Predict Metoprolol Disposition in Healthy and Disease Populations.ACS omega · 2023Article
- Informing a Comprehensive Risk Assessment of Infant Drug Exposure From Human Milk: Application of a Physiologically Based Pharmacokinetic Lactation Model for Sotalol.Journal of clinical pharmacology · 2023Article
- Application of a physiologically based pharmacokinetic model in predicting captopril disposition in children with chronic kidney disease.Scientific reports · 2023Article
- Prediction of pediatric dose of tirzepatide from the reference adult dose using physiologically based pharmacokinetic modelling.Frontiers in pharmacology · 2023Article
- Physiologically-Based Pharmacokinetic Modeling to Predict Methylphenidate Exposure Affected by Interplay Among Carboxylesterase 1 Pharmacogenetics, Drug-Drug Interactions, and Sex.Journal of pharmaceutical sciences · 2022Article
- Use of Antibiotics in Preterm Newborns.Antibiotics (Basel, Switzerland) · 2022Review
- Prediction of Carboxylesterase 1-mediated In Vivo Drug Interaction between Methylphenidate and Cannabinoids using Static and Physiologically Based Pharmacokinetic Models.Drug metabolism and disposition: the biological fate of chemicals · 2022Article
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- Development and evaluation of physiologically based pharmacokinetic drug-disease models for predicting captopril pharmacokinetics in chronic diseases.Scientific reports · 2021Article
- Comparing Predictions of a PBPK Model for Cyclosporine With Drug Levels From Therapeutic Drug Monitoring.Frontiers in pharmacology · 2021Article
- Development and Evaluation of a Physiologically Based Pharmacokinetic Drug-Disease Model of Propranolol for Suggesting Model Informed Dosing in Liver Cirrhosis Patients.Drug design, development and therapy · 2021Article
Corrections and comments
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Authors and funding
2 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In recent years, the increased interest in pediatric research has enforced the role of physiologically based pharmacokinetic (PBPK) models in pediatric drug development. However, an existing lack of published examples contributes to some uncertainties about the reliability of their predictions of oral drug exposure. Developing and validating pediatric PBPK models for oral drug application shall enrich our knowledge about their limitations and lead to a better use of the generated data. This study was conducted to investigate how whole-body PBPK models describe the oral pharmacokinetics of sotalol over the entire pediatric age. Two leading software tools for whole-body PBPK modeling: Simcyp® (Simcyp Ltd, Sheffield, UK) and PK-SIM® (Bayer Technology Services GmbH, Leverkusen, Germany), were used. Each PBPK model was first validated in adults before scaling to children. Model input parameters were collected from the literature and clinical data for 80 children were used to compare predicted and observed values. The results obtained by both models were comparable and gave an adequate description of sotalol pharmacokinetics in adults and in almost all pediatric age groups. Only in neonates, the mean ratio(Obs/Pred) for any PK parameter exceeded a twofold error range, 2.56 (95% confidence interval (CI), 2.10-3.49) and 2.15 (95% CI, 1.77-2.99) for area under the plasma concentration-time curve from the first to the last concentration point and maximal concentration (Cmax) using SIMCYP® and 2.37 (95% CI, 1.76-3.25) for time to reach Cmax using PK-SIM®. The two PBPK models evaluated in this study reflected properly the age-related pharmacokinetic changes and predicted adequately the oral sotalol exposure in children of different ages, except in neonates.
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