ArticleBritish journal of clinical pharmacology2019
Commentary on the EMA Reflection Paper on the use of extrapolation in the development of medicines for paediatrics.
Article in British journal of clinical pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 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
22 citing papers in PubMed.
- Application of a Stochastic Simulation-estimation Approach to Optimize Pharmacokinetic Study Design in the Context of Paediatric Extrapolation: A Tool to Support Decision-making by Drug Sponsors and Regulators.Pharmaceutical research · 2026Article
- Era of surrogate endpoints and accelerated approvals: a comprehensive review on applicability, uncertainties, and challenges from regulatory, payer, and patient perspectives.European journal of clinical pharmacology · 2025Review
- Acceptance of Evidence Transfer Within German Early Benefit Assessment of New Drugs for Pediatric and Adolescents Target Populations.PharmacoEconomics · 2025Article
- Safety reporting in neonatal clinical trials: reflections towards optimal, globally relevant approaches.Trials · 2025Article
- All You Need to Know About Allometric Scaling: An Integrative Review on the Theoretical Basis, Empirical Evidence, and Application in Human Pharmacology.Clinical pharmacokinetics · 2025Review
- Physiologically-based pharmacokinetic models versus allometric scaling for prediction of tyrosine-kinase inhibitor exposure from adults to children.Cancer chemotherapy and pharmacology · 2024Article
- Article
- Current knowledge, challenges and innovations in developmental pharmacology: A combined conect4children Expert Group and European Society for Developmental, Perinatal and Paediatric Pharmacology White Paper.British journal of clinical pharmacology · 2022Review
- Extrapolation as a Default Strategy in Pediatric Drug Development.Therapeutic innovation & regulatory science · 2022Article
- Clinical trial diversity: An opportunity for improved insight into the determinants of variability in drug response.British journal of clinical pharmacology · 2022Review
- Description of a clinical decision support tool with integrated dose calculator for paediatrics.European journal of pediatrics · 2022Article
- Ceftaroline Fosamil for Treatment of Pediatric Complicated Skin and Soft Tissue Infections and Community-Acquired Pneumonia.Paediatric drugs · 2021Review
- Personalised Tasted Masked Chewable 3D Printed Fruit-Chews for Paediatric Patients.Pharmaceutics · 2021Article
- The use of extrapolation based on modeling and simulation to support high-dose regimens of ceftaroline fosamil in pediatric patients with complicated skin and soft-tissue infections.CPT: pharmacometrics & systems pharmacology · 2021Article
- Prospect of Direct Benefit in Pediatric Trials: Practical Challenges and Potential Solutions.Pediatrics · 2021Article
- Are Novel, Nonrandomized Analytic Methods Fit for Decision Making? The Need for Prospective, Controlled, and Transparent Validation.Clinical pharmacology and therapeutics · 2020Review
- Power gains by using external information in clinical trials are typically not possible when requiring strict type I error control.Biometrical journal. Biometrische Zeitschrift · 2020Article
- Developmental Pharmacodynamics and Modeling in Pediatric Drug Development.Journal of clinical pharmacology · 2019Review
- Could Postnatal Age-Related Uridine Diphosphate Glucuronic Acid Be a Rate-Limiting Factor in the Metabolism of Morphine During the First Week of Life?CPT: pharmacometrics & systems pharmacology · 2019Article
- New Strategies for the Conduct of Clinical Trials in Pediatric Pulmonary Arterial Hypertension: Outcome of a Multistakeholder Meeting With Patients, Academia, Industry, and Regulators, Held at the European Medicines Agency on Monday, June 12, 2017.Journal of the American Heart Association · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Adopted guidelines reflect a harmonised European approach to a specific scientific issue and should reflect the most recent scientific knowledge. However, whilst EU regulations are mandatory for all member states and EU directives must be followed by national laws in line with the directive, EMA guidelines do not have legal force and alternative approaches may be taken, but these obviously require more justification. This new series of the BJCP, developed in collaboration with the EMA, aims to address this issue by providing an annotated version of some relevant EMA guidelines and regulatory documents by experts. Hopefully, this will help in promoting their diffusion and in opening a forum for discussion with our readers.
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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.