ArticleInternational journal of pharmaceutics2018
Challenges and strategies to facilitate formulation development of pediatric drug products: Safety qualification of excipients.
Article in International journal of pharmaceutics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 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.
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Who cites it
15 citing papers in PubMed.
- Assessment of Taste and Grittiness of RiometDrugs in R&D · 2019Trial
- Comparison of Safety and Efficacy of Methadone vs Morphine for Treatment of Neonatal Abstinence Syndrome: A Randomized Clinical Trial.JAMA pediatrics · 2018Trial
- Evaluation of Ease of Use for Pediatric Medications Requiring Decapsulation, Dissolution, or Partial Dosing: A Questionnaire-Based Study in Japan.Therapeutic innovation & regulatory science · 2026Article
- A Quantitative Review of Un-licensed and Off-label Medicines Use in Children Aged 0-2 Years in the Private Sector in South Africa: Extent, Challenges, and Implications.Current pediatric reviews · 2026Article
- Surfactant-Particle Engineering Hybrids: Emerging Strategies for Enhancing Solubility and Oral Bioavailability of Poorly Water-Soluble Drugs.Pharmaceutics · 2025Review
- KollicoatPharmaceutics · 2025Article
- Formulation Challenges and Strategies to Develop Pediatric Dosage Forms.Children (Basel, Switzerland) · 2022Review
- The Current States, Challenges, Ongoing Efforts, and Future Perspectives of Pharmaceutical Excipients in Pediatric Patients in Each Country and Region.Children (Basel, Switzerland) · 2022Review
- Excipients in the Paediatric Population: A Review.Pharmaceutics · 2021Review
- Development of nanoparticle-based orodispersible palatable pediatric formulations.International journal of pharmaceutics · 2021Article
- Safety and Biopharmaceutical Challenges of Excipients in Off-Label Pediatric Formulations.International journal of general medicine · 2020Review
- Pediatric Safety of Polysorbates in Drug Formulations.Children (Basel, Switzerland) · 2019Article
- How to Modify Drug Release in Paediatric Dosage Forms? Novel Technologies and Modern Approaches with Regard to Children's Population.International journal of molecular sciences · 2019Review
- Excipients in Neonatal Medicinal Products: Never Prescribed, Commonly Administered.Pharmaceutical medicine · 2018Article
- Review
Corrections and comments
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Authors and funding
6 authors.
Funding
Abstract
A public workshop entitled "Challenges and strategies to facilitate formulation development of pediatric drug products" focused on current status and gaps as well as recommendations for risk-based strategies to support the development of pediatric age-appropriate drug products. Representatives from industry, academia, and regulatory agencies discussed the issues within plenary, panel, and case-study breakout sessions. By enabling practical and meaningful discussion between scientists representing the diversity of involved disciplines (formulators, nonclinical scientists, clinicians, and regulators) and geographies (eg, US, EU), the Excipients Safety workshop session was successful in providing specific and key recommendations for defining paths forward. Leveraging orthogonal sources of data (eg. food industry, agro science), collaborative data sharing, and increased awareness of the existing sources such as the Safety and Toxicity of Excipients for Paediatrics (STEP) database will be important to address the gap in excipients knowledge needed for risk assessment. The importance of defining risk-based approaches to safety assessments for excipients vital to pediatric formulations was emphasized, as was the need for meaningful stakeholder (eg, patient, caregiver) engagement.
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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.