ReviewPharmaceutics2023
Pediatric Drug Development: Reviewing Challenges and Opportunities by Tracking Innovative Therapies.
Review in Pharmaceutics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 25 papers, 1 of them a synthesis 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
25 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Outlook of Cell Gene Therapies Development and Approval from Quality and Regulatory Perspective.Therapeutic innovation & regulatory science · 2026Pooled it
- Multicenter Evaluation of Ceftazidime/Avibactam in Pediatric Patients Across the United States: Real-World Insights into the Management of Drug-Resistant Gram-Negative Infections.Open forum infectious diseases · 2026Trial
- Taste Profile and Relative Bioavailability of Tovorafenib Powder for Oral Suspension and Food Effect of the Tovorafenib Tablet in Healthy Participants.Clinical pharmacology in drug development · 2025Trial
- Pediatric Anesthesia: Excellence in Patient Care.Journal of clinical medicine · 2026Article
- Developmental candidate GHP-88310/EIDD-3608 with high tolerability and oral efficacy in measles and respiratory paramyxovirus models.Science advances · 2026Article
- Optimising Paediatric Medication Adherence Through Innovative Drug Formulations and Delivery Systems.Clinical pharmacokinetics · 2026Review
- Bridging disciplinary siloes: a scoping review on the inclusion and exclusion of pregnant and lactating populations in clinical research.BMJ public health · 2026Article
- Ethical oversight of AI-driven paediatric trials: a proactive, risk-sensitive interim review model.Frontiers in digital health · 2026Article
- Target product profile for the development of pediatric formulations of new drugs for the treatment of children with T. cruzi infection.PLoS neglected tropical diseases · 2026Review
- [Drug Excipients. Necessary, but not Harmless].Farmaceuticos comunitarios · 2025Review
- Genetic renaissance: a cross-regional analysis of the approval landscape of authorised gene therapeutics in paediatrics, challenges and future prospects.Journal of community genetics · 2025Article
- Formulation of Recombinant Therapeutic Proteins: Technological Innovation, Regulations, and Evolution Towards Buffer-Free Formulations.Pharmaceutics · 2025Review
- Advancements and Future Perspectives of Microfluidic Technology in Pediatric Healthcare.Smart medicine · 2025Review
- Utilization of Child-Appropriate Medicines: Use of Pediatric Use Marketing Authorisation (PUMA) Products in Croatia.Journal of clinical medicine · 2025Article
- Correction: Domingues et al. Pediatric Drug Development: Reviewing Challenges and Opportunities by Tracking Innovative Therapies.Pharmaceutics · 2025Article
- Clinical data required for the approval of pediatric pharmaceuticals in Japan.BMC pediatrics · 2025Article
- Development and Characterization of Niaprazine-Loaded Xanthan Gum-Based Gel for Oral Administration.Gels (Basel, Switzerland) · 2025Article
- Adverse events in the neonatal intensive care unit identified by triggers.Frontiers in pharmacology · 2025Article
- Applications of Chitosan in Prevention and Treatment Strategies of Infectious Diseases.Pharmaceutics · 2024Review
- Paediatric Drug Development in China: Current Status and Future Prospects.Paediatric drugs · 2024Review
Corrections and comments
- Erratum issued
Authors and funding
5 authors.
Funding
Abstract
The paradigm of pediatric drug development has been evolving in a "carrot-and-stick"-based tactic to address population-specific issues. However, the off-label prescription of adult medicines to pediatric patients remains a feature of clinical practice, which may compromise the age-appropriate evaluation of treatments. Therefore, the United States and the European Pediatric Formulation Initiative have recommended applying nanotechnology-based delivery systems to tackle some of these challenges, particularly applying inorganic, polymeric, and lipid-based nanoparticles. Connected with these, advanced therapy medicinal products (ATMPs) have also been highlighted, with optimistic perspectives for the pediatric population. Despite the results achieved using these innovative therapies, a workforce that congregates pediatric patients and/or caregivers, healthcare stakeholders, drug developers, and physicians continues to be of utmost relevance to promote standardized guidelines for pediatric drug development, enabling a fast lab-to-clinical translation. Therefore, taking into consideration the significance of this topic, this work aims to compile the current landscape of pediatric drug development by (1) outlining the historic regulatory panorama, (2) summarizing the challenges in the development of pediatric drug formulation, and (3) delineating the advantages/disadvantages of using innovative approaches, such as nanomedicines and ATMPs in pediatrics. Moreover, some attention will be given to the role of pharmaceutical technologists and developers in conceiving pediatric medicines.
Indexed as
Identifiers
What Socratic 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 Socratic graph.