Although some drugs have been developed for the neonate, drug development for the least mature and most vulnerable pediatric patients is lacking. Most of the drugs are off-label or off-patent and are empirically administered to newborns once efficacy has been demonstrated in adults and usefulness is suspected or demonstrated in the older pediatric population. Few drugs are approved by the Food and Drug Administration for use in this population. The factors that prevent the demonstration of efficacy and safety in the newborn are discussed and a change in the current approach for neonatal drug studies is suggested.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.clp.2011.12.016 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Clozapine for Treatment-Resistant Disruptive Behaviors in Youths With Autism Spectrum Disorder Aged 10-17 Years: Protocol for an Open-Label Trial.
JMIR Res Protoc
January 2025
Graduate Program of Psychiatry and Behavioral Sciences, Department of Psychiatry, Federal University of Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.
Background: Autism Spectrum Disorder (ASD) is a complex neurodevelopmental condition emerging in early childhood, characterized by core features such as sociocommunicative deficits and repetitive, rigid behaviors, interests, and activities. In addition to these, disruptive behaviors (DB), including aggression, self-injury, and severe tantrums, are frequently observed in pediatric patients with ASD. The atypical antipsychotics risperidone and aripiprazole, currently the only Food and Drug Administration-approved treatments for severe DB in patients with ASD, often encounter therapeutic failure or intolerance.
View Article and Find Full Text PDFLong-Term Treatment With Ocrelizumab in Patients With Early-Stage Relapsing MS: Nine-Year Data From the OPERA Studies Open-Label Extension.
Neurology
February 2025
Department of Neurology and Center of Clinical Neuroscience, First Medical Faculty, General University Hospital and Charles University, Prague, Czech Republic.
Background And Objectives: Patients with multiple sclerosis (MS) may demonstrate better disease control when treatment is initiated on high-efficacy disease-modifying therapies (DMTs) from onset. This subgroup analysis assessed the long-term efficacy and safety profile of the high-efficacy DMT ocrelizumab (OCR) as first-line therapy for early-stage relapsing MS (RMS).
Methods: Post hoc exploratory analyses of efficacy and safety were performed in a subgroup of treatment-naive patients with RMS who received ≥1 dose of OCR in the multicenter OPERA I/II (NCT01247324/NCT01412333) studies.
Oral Cyclophosphamide for Patients With Metastatic Castration-Resistant Prostate Cancer in a Scenario of Limited Health Care Resources.
JCO Glob Oncol
January 2025
Genitourinary Medical Oncology Service, Instituto do Câncer do Estado de São Paulo (ICESP), University of São Paulo, São Paulo, Brazil.
Purpose: Prior noncontemporary studies showed that oral cyclophosphamide is an active treatment of metastatic castration-resistant prostate cancer (mCRPC). However, cyclophosphamide is currently underutilized in routine clinical practice given the lack of survival benefit and the emergence of more effective treatments.
Methods: We retrospectively reviewed our institutional database to identify patients with mCRPC treated with cyclophosphamide.
Forecasting Asparaginase Need and Cost for Childhood Cancer Using ACCESS FORxECAST.
JCO Glob Oncol
January 2025
Division of Haematology/Oncology, The Hospital for Sick Children, Toronto, Canada.
Purpose: Asparaginase (ASN) is a critical component of pediatric ALL protocols. Until recently, ASN was available in three formulations: native Escherichia coli, PEGylated E. coli (PEG), and Erwinase, with native E.
View Article and Find Full Text PDFGlobal antibiotic prescription practices in hospitals and associated factors: a systematic review and meta-analysis.
J Glob Health
January 2025
Department of Social Medicine and Health Management, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.
Background: The prevalence of antibiotic prescribing among total prescriptions, the percentage of combined antibiotic prescribing among prescriptions containing at least one antibiotic, and factors influencing hospital antibiotic prescribing are currently unknown. In this systematic review, we aimed to summarise antibiotic prescribing in hospitals worldwide and identify the associated factors.
Methods: We searched PubMed/MEDLINE, Ovid/Embase, and the Web of Science for articles published between 1 January 2000 and 28 February 2023 that reported antibiotic prescribing in hospitals or the associated factors.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!