Evidence map›Paper›PMID 29173779›Full record

ReviewPediatric clinics of North America2017

Development of Drug Therapies for Newborns and Children: The Scientific and Regulatory Imperatives.

Yeruk Lily Mulugeta, Anne Zajicek, Jeff Barrett, Hari Cheryl Sachs, Susan McCune, Vikram Sinha, Lynne Yao

Open access · greenAbstract readReview
In one paragraph

Review in Pediatric clinics of North America, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
3.7field-weighted citation impact, top 7% of its field
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

12 citing papers in PubMed, 29 citations in OpenAlex.

  1. Review
  2. Review
  3. Paediatric Drug Development in Japan: Current Status and Future Challenges.Therapeutic innovation & regulatory science · 2025
    Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Review
  11. Review
  12. 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

7 authors at 4 institutions in 1 country.

Yeruk Lily MulugetaDivision of Pediatric and Maternal Health, CDER US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20903, USA. Electronic address: yeruk.mulugeta@fda.hhs.gov.
Anne ZajicekObstetric and Pediatric Pharmacology and Therapeutics Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6710B Rockledge Drive Room 2334, MSC 7002, Bethesda, MD 20817, USA.
Jeff BarrettSanofi Pharmaceuticals, Discovery Drive, Swiftwater, PA 18370, USA.
Hari Cheryl SachsDivision of Pediatric and Maternal Health, CDER US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20903, USA.
Susan McCuneDivision of Pediatric and Maternal Health, CDER US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20903, USA.
Vikram SinhaMerck & Co., Inc, PO Box 1000, UG4D-48, North Wales, PA 19454, USA.
Lynne YaoDivision of Pediatric and Maternal Health, CDER US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20903, USA.
United States Food and Drug Administration · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USMerck & Co., Inc., Rahway, NJ, USA (United States) · USSanofi (United States) · US

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

Pediatric legislation has generated information about the efficacy, safety, and dosing of more than 600 products in children. Extrapolation of adult efficacy data has been an integral part of pediatric drug development. Advances in our understanding of physiology and pharmacology have improved the approach to pediatric dose selection. However, a high percentage of pediatric trials do not meet their primary efficacy endpoint. Delays in initiating completing pediatric studies persist. This article describes these advances and provides innovative approaches to optimize pediatric drug development.

Indexed as

Dose-Response Relationship, DrugDrug IndustryAdultAge FactorsChildHumansInfant, NewbornPediatricsResearch DesignUnited StatesUnited States Food and Drug AdministrationDosingExtrapolationNeonatalPediatricRegulationsResearch

Identifiers

PMID29173779
PMCPMC5765998
OpenAlexW2770799084

What OpenQuestion holds

Textmetadata
LicenceTDM
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.