ReviewCPT: pharmacometrics & systems pharmacology2022
Quantitative system pharmacology as a legitimate approach to examine extrapolation strategies used to support pediatric drug development.
Review in CPT: pharmacometrics & systems pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed.
- Pediatric Developmental Safety Assessment and New Approach Methodologies: US FDA/Triangle CERSI Workshop Report.Clinical pharmacology and therapeutics · 2026Review
- From Small Data to Big Decisions: How Clinical Pharmacology Shapes Rare Disease Development.Journal of clinical pharmacology · 2026Review
- Accelerating Pediatric Oncology Drug Development: Advances in Clinical Pharmacology, Trial Design, Non-Clinical Evidence, and Regulatory Science.Journal of clinical pharmacology · 2026Review
- Application of Quantitative Systems Pharmacology Approaches to Support Pediatric Labeling in Rare Diseases.Handbook of experimental pharmacology · 2025Review
- Challenges, approaches and enablers: effectively triangulating towards dose selection in pediatric rare diseases.Journal of pharmacokinetics and pharmacodynamics · 2023Review
- Achieving big with small: quantitative clinical pharmacology tools for drug development in pediatric rare diseases.Journal of pharmacokinetics and pharmacodynamics · 2023Review
- Pediatric oncology drug development and dosage optimization.Frontiers in oncology · 2023Review
- Quantitative system pharmacology as a legitimate approach to examine extrapolation strategies used to support pediatric drug development.CPT: pharmacometrics & systems pharmacology · 2022Review
- Advancing rare disease measurement through the Rare Disease Clinical Outcome Assessment Consortium.Therapeutic advances in rare diseaseReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Extrapolation strategies from adult data for designing pediatric drug development programs are explored using the quantitative systems pharmacology (QSP) modeling approach, a mechanistic drug and disease modeling framework that can predict clinical response and guide pediatric drug development in general. This innovative model-informed drug discovery and development approach can leverage adult-pediatric pharmacology and disease similarity metrics to validate extrapolation assumptions. We describe the QSP model strategy and framework for extrapolation to design pediatric drug development programs by leveraging adult data across a wide range of therapeutic areas and illustrating stage-gate decisions informed by such an approach.
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What OpenQuestion holds
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.