ArticlePaediatric drugs2012
From adults to children: simulation-based choice of an appropriate sparse-sampling schedule.
Article in Paediatric drugs, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00468819 (Open-label Multi-center Study of Magnetic Resonance Imaging), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Open-label Multi-center Study of Magnetic Resonance Imaging (MRI) With 0.1 mmol/kg Body Weight (BW) Gadavist (1.0 M) to Assess Pharmacokinetics, Safety and Tolerability in Children.
Who cites it
2 citing papers in PubMed.
- Model-Based Assessment of Alternative Study Designs in Pediatric Trials. Part I: Frequentist Approaches.CPT: pharmacometrics & systems pharmacology · 2016Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAccording to the International Conference on Harmonisation guideline E11, pharmacokinetic (PK) bridging studies can be applied to support pediatric drug development. However, for PK studies in infants and children the sampling schedule needs to be optimized to minimize the number of blood samples per individual.
objectiveThe aim of this study was to describe how clinical trial simulations (CTS) based on adult data were used to select an appropriate sparse-sampling schedule for a future pediatric population PK (popPK) study.
methodsA popPK model for gadobutrol (Gadovist®) was developed using data from a phase I study in adults. This model was used for CTS to select the most appropriate sparse-sampling schedule that met predefined acceptance criteria. This sampling schedule was applied in a pediatric clinical phase I/III study. Non-linear mixed-effects modeling was used for PK modeling and simulations.
resultsAn appropriate sampling schedule requiring only three blood samples per patient was selected and successfully applied in a pediatric study with a gadobutrol standard dose of 0.1 mmol/kg bodyweight. A popPK analysis was performed to determine individual PK parameters in the pediatric study population.
conclusionsA priori evaluation of selected sampling schedules by simulation from adult data provides a useful tool for efficient planning of pediatric studies.
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Registered trials
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