ReviewPharmaceutics2010
Drug Development for Pediatric Populations: Regulatory Aspects.
Review in Pharmaceutics, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 papers, 4 of them syntheses that pooled it.
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
41 citing papers in PubMed, 4 syntheses or guidelines pooled it, 103 citations in OpenAlex.
- Population Pharmacokinetic/Pharmacodynamic Modeling of Therapeutic Enzymes in Lysosomal Storage Diseases.Clinical pharmacokinetics · 2026Pooled it
- Pooled it
- Effect of propofol and remifentanil on cerebral perfusion and oxygenation in pigs: a systematic review.Acta veterinaria Scandinavica · 2016Pooled it
- Population pharmacokinetic analysis of oxaliplatin in adults and children identifies important covariates for dosing.Cancer chemotherapy and pharmacology · 2015Pooled it
- Baseline Characteristics of Pediatric Patients With Heart Failure Due to Systemic Left Ventricular Systolic Dysfunction in the PANORAMA-HF Trial.Circulation. Heart failure · 2023Trial
- Challenges in conducting trials for pediatric tuberculous meningitis: lessons from the field.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2019Trial
- Model Informed Pediatric Development Applied to Bilastine: Ontogenic PK Model Development, Dose Selection for First Time in Children and PK Study Design.Pharmaceutical research · 2017Trial
- Nanotechnology in Pediatric Neurology: Applications and Innovations.Pharmaceutics · 2026Review
- Strategies for pediatric dose derivation from population pharmacokinetic models.Journal of pharmacokinetics and pharmacodynamics · 2026Article
- Drug prescription for patients treated by dialysis: navigation in the fog.Clinical kidney journal · 2026Article
- Use of Modeling and Simulation to Inform the Development of Monoclonal Antibodies to Treat Moderate-to-Severe Asthma: A Retrospective Review of EMA Centralized Procedure From 2014 to 2024.CPT: pharmacometrics & systems pharmacology · 2026Article
- Multiscale physiologically-based model of age-dependent CD4+ T-lymphocyte homeostasis.Frontiers in immunology · 2026Article
- Describing Inconsistencies in Pediatric Labeling of Medical Devices.JAMA network open · 2025Article
- A Novel Approach to Evaluating the Design of Pediatric Pharmacokinetic Studies Focused on Accurate Dose Selection.Clinical pharmacokinetics · 2025Article
- Overcoming bioanalytical challenges during the development of risdiplam for the treatment of spinal muscular atrophy.Bioanalysis · 2025Article
- The efficacy and safety of acetylcysteine combined with budesonide nebulization in treating mycoplasma pneumonia in children: a meta-analysis.Frontiers in pediatrics · 2025Review
- A matrix tool to foster patient engagement in children, adolescents and young adults: report from a multistakeholder workshop.Research involvement and engagement · 2024Article
- State of the art in pediatric nanomedicines.Drug delivery and translational research · 2024Review
- Sex as a Biological Variable in Early-Phase Oncology Clinical Trials: Enhancing the Path to Personalised Medicine.Heliyon · 2024Review
- Pediatric Formulations Developed by Extrusion-Based 3D Printing: From Past Discoveries to Future Prospects.Pharmaceutics · 2024Review
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 at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Pediatric aspects are nowadays integrated early in the development process of a new drug. The stronger enforcement to obtain pediatric information by the regulatory agencies in recent years resulted in an increased number of trials in children. Specific guidelines and requirements from, in particular, the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) form the regulatory framework. This review summarizes the regulatory requirements and strategies for pediatric drug development from an industry perspective. It covers pediatric study planning and conduct, considerations for first dose in children, appropriate sampling strategies, and different methods for data generation and analysis to generate knowledge about the pharmacokinetics (PK) and pharmacodynamics (PD) of a drug in children. The role of Modeling and Simulation (M&S) in pediatrics is highlighted-including the regulatory basis-and examples of the use of M&S are illustrated to support pediatric drug development.
Indexed as
Identifiers
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.