ArticleBritish journal of clinical pharmacology2015
Optimizing pharmacokinetic bridging studies in paediatric oncology using physiologically-based pharmacokinetic modelling: application to docetaxel.
Article in British journal of clinical pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis that pooled it.
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Who cites it
25 citing papers in PubMed, 1 synthesis or guideline pooled it, 44 citations in OpenAlex.
- Utility of physiologically based pharmacokinetic (PBPK) modeling in oncology drug development and its accuracy: a systematic review.European journal of clinical pharmacology · 2018Pooled it
- Application of Pharmacometric Modelling Towards Precise Dosing in Neonates, Infants and Toddlers: A Scoping Review.Clinical pharmacokinetics · 2026Review
- Accelerating Pediatric Oncology Drug Development: Advances in Clinical Pharmacology, Trial Design, Non-Clinical Evidence, and Regulatory Science.Journal of clinical pharmacology · 2026Review
- Design Optimization for Developing Population Pharmacokinetic Models in Critically Ill Children: Application to Teicoplanin, Piperacillin and Meropenem.Clinical pharmacokinetics · 2026Article
- Physiologically Based Pharmacokinetic Modeling of Digoxin in Adult and Pediatric Patients with Heart Failure.Pharmaceutics · 2026Article
- Opportunities for machine learning and artificial intelligence in physiologically-based pharmacokinetic (PBPK) modeling.Advanced drug delivery reviews · 2025Review
- Docetaxel, cyclophosphamide, and epirubicin: application of PBPK modeling to gain new insights for drug-drug interactions.Journal of pharmacokinetics and pharmacodynamics · 2024Article
- Physiologically Based Pharmacokinetic Modeling in Neonates: Current Status and Future Perspectives.Pharmaceutics · 2023Review
- Utility of Physiologically Based Pharmacokinetic Modeling to Investigate the Impact of Physiological Changes of Pregnancy and Cancer on Oncology Drug Pharmacokinetics.Pharmaceutics · 2023Article
- 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
- Ethics of age de-escalation in pediatric vaccine trials: Attending to the case of COVID-19.Vaccine · 2023Article
- Pediatric oncology drug development and dosage optimization.Frontiers in oncology · 2023Review
- A PBPK model recapitulates early kinetics of anti-PEG antibody-mediated clearance of PEG-liposomes.Journal of controlled release : official journal of the Controlled Release Society · 2022Article
- Pharmacometric estimation methods for aggregate data, including data simulated from other pharmacometric models.Journal of pharmacokinetics and pharmacodynamics · 2021Article
- Utilization of Physiologically Based Pharmacokinetic Modeling in Clinical Pharmacology and Therapeutics: an Overview.Current pharmacology reports · 2020Review
- Physiologically Based Pharmacokinetic Modelling of Hyperforin to Predict Drug Interactions with St John's Wort.Clinical pharmacokinetics · 2019Article
- Mind the Gaps: Ontogeny of Human Brain P-gp and Its Impact on Drug Toxicity.The AAPS journal · 2019Review
- Accelerating Drug Development in Pediatric Oncology With the Clinical Pharmacology Storehouse.Journal of clinical pharmacology · 2019Review
- A Retrospective Evaluation of Allometry, Population Pharmacokinetics, and Physiologically-Based Pharmacokinetics for Pediatric Dosing Using Clearance as a Surrogate.CPT: pharmacometrics & systems pharmacology · 2019Article
- Physiologically Based Pharmacokinetic Modeling for Olaparib Dosing Recommendations: Bridging Formulations, Drug Interactions, and Patient Populations.Clinical pharmacology and therapeutics · 2019Article
Corrections and comments
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Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimApplying physiologically-based pharmacokinetic (PBPK) modelling in paediatric cancer drug development is still challenging. We aimed to demonstrate how PBPK modelling can be applied to optimize dose and sampling times for a paediatric pharmacokinetic (PK) bridging study in oncology and to compare with the allometric scaling population PK (AS-popPK) approach, using docetaxel as an example.
methodsA PBPK model for docetaxel was first developed for adult cancer patients using Simcyp® and subsequently used to predict its PK profiles in children by accounting for age-dependent physiological differences. Dose (mg m(-2) ) requirements for children aged 0-18 years were calculated to achieve targeted exposure in adults. Simulated data were then analyzed using population PK modelling with MONOLIX® in order to perform design optimization with the population Fisher information matrix (PFIM). In parallel, the AS-popPK approach was performed for the comparison.
resultsThe PBPK model developed for docetaxel adequately predicted its PK profiles in both adult and paediatric cancer patients (predicted clearance and volume of distribution within 1.5 fold of observed data). The revised dose of docetaxel for a child over 1.5 years old was higher than the adult dose. Considering clinical constraints, the optimal design contained two groups of 15 patients, having three or four sampling times and had good predicted relative standard errors (RSE<30%) for almost all parameters. The AS-popPK approach performed reasonably well but could not predict for very young children.
conclusionThis research shows the clinical utility of PBPK modelling in combination with population PK modelling and optimal design to support paediatric oncology development.
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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.