Evidence map›Paper›PMID 39935560›Full record

ArticleThe journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG2025

A Pediatric Research Imperative: Addressing Neonates in Drug Development Through Understanding Neonatal Clinical Pharmacology.

An N Massaro, Elimika Pfuma Fletcher, Rajanikanth Madabushi, Gerri Baer, Dionna Green

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

An N MassaroOffice of Pediatric Therapeutics, Office of the Chief Medical Officer, Office of the Commissioner, US FDA (DG, ANM), Silver Spring, MD.
Elimika Pfuma FletcherOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US FDA (EPF, RM), Silver Spring, MD.
Rajanikanth MadabushiOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US FDA (EPF, RM), Silver Spring, MD.
Gerri BaerDivision of Hepatology and Nutrition, Office of New Drugs, Center for Drug Evaluation and Research, US FDA (GB), Silver Spring, MD.
Dionna GreenOffice of Pediatric Therapeutics, Office of the Chief Medical Officer, Office of the Commissioner, US FDA (DG, ANM), Silver Spring, MD.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Drug development in the neonatal population remains an unmet need in health care. While incentives and legislative mandates have had some impact on increasing drug development in pediatric patients, the advancement of neonatal therapeutics faces unique challenges. This review summarizes relevant regulatory history, clinical, pharmacological and ethical considerations that characterize the landscape of drug development in neonates. Research priorities and future directions for advancing safe and effective medicines for the vulnerable neonatal population are discussed.

Indexed as

drug developmentneonatepharmacologypreterm infant

Identifiers

PMID39935560
PMCPMC11809530

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.