Evidence map›Paper›PMID 35466995›Full record

ReviewDisease models & mechanisms2022

The benefits, limitations and opportunities of preclinical models for neonatal drug development.

Sarah Campion, Amy Inselman, Belinda Hayes, Costanza Casiraghi, David Joseph, Fabrizio Facchinetti, Fabrizio Salomone, Georg Schmitt, Julia Hui, Karen Davis-Bruno and 9 more

Open access · goldAbstract readReview
In one paragraph

Review in Disease models & mechanisms, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.2field-weighted citation impact, top 21% 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

5 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Pet Wellness and Vitamin A: A Narrative Overview.Animals : an open access journal from MDPI · 2024
    Review
  5. 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

19 authors at 11 institutions in 5 countries.

Sarah CampionPfizer Worldwide Research, Development, and Medical, Groton, CT 06340, USA.ORCID 0000-0002-8328-7718
Amy InselmanU.S. Food and Drug Administration, National Center for Toxicological Research, Division of Systems Biology, Jefferson, AR 72079, USA.ORCID 0000-0002-3335-7482
Belinda HayesU.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Silver Spring, MD 20993, USA.
Costanza CasiraghiDepartment of Experimental Pharmacology and Translational Science, Chiesi Farmaceutici S.p.A., 43122 Parma, Italy.ORCID 0000-0001-6225-5250
David JosephU.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Silver Spring, MD 20993, USA.
Fabrizio FacchinettiDepartment of Experimental Pharmacology and Translational Science, Chiesi Farmaceutici S.p.A., 43122 Parma, Italy.
Fabrizio SalomoneDepartment of Experimental Pharmacology and Translational Science, Chiesi Farmaceutici S.p.A., 43122 Parma, Italy.ORCID 0000-0002-9083-3932
Georg SchmittPharma Research and Early Development, Roche Innovation Center Basel, Pharmaceutical Sciences, F. Hoffmann-La Roche, 4070 Basel, Switzerland.
Julia HuiBristol Myers Squibb, Nonclinical Research and Development, Summit, NJ 07901, USA.
Karen Davis-BrunoU.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Silver Spring, MD 20993, USA.
Karen Van MalderenFederal Agency for Medicines and Health Products (FAMHP), Department DG PRE authorization, 1210 Brussels, Belgium.
LaRonda MorfordEli Lilly, Global Regulatory Affairs, Indianapolis, IN 46285, USA.
Luc De SchaepdrijverJanssen R&D, Preclinical Sciences & Translational Safety, 2340 Beerse, Belgium.ORCID 0000-0001-9653-7627
Lutz WiesnerFederal Institute for Drugs and Medical Devices, Clinical Trials, 53175 Bonn, Germany.
Stephanie KourulaJanssen R&D, Drug Metabolism & Pharmacokinetics, 2340 Beerse, Belgium.ORCID 0000-0002-7667-7072
Suna SeoU.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Silver Spring, MD 20993, USA.
Susan LaffanGlaxoSmithKline, Non-Clinical Safety, Collegeville, PA 19406, USA.ORCID 0000-0001-8439-7700
Vijay UrmaliyaJanssen R&D, Discovery Sciences, 2340 Beerse, Belgium.
Connie ChenHealth and Environmental Sciences Institute, Washington, DC 20005, USA.
United States Food and Drug Administration · USChiesi Foundation · ITJanssen (Belgium) · BEBristol-Myers Squibb (United States) · USEli Lilly (United States) · USFederal Institute for Drugs and Medical Devices · DEGlaxoSmithKline (United States) · USHealth and Environmental Sciences Institute · USNational Center for Toxicological Research · USPfizer (United States) · USRoche (Switzerland) · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Increased research to improve preclinical models to inform the development of therapeutics for neonatal diseases is an area of great need. This article reviews five common neonatal diseases - bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, perinatal hypoxic-ischemic encephalopathy and neonatal sepsis - and the available in vivo, in vitro and in silico preclinical models for studying these diseases. Better understanding of the strengths and weaknesses of specialized neonatal disease models will help to improve their utility, may add to the understanding of the mode of action and efficacy of a therapeutic, and/or may improve the understanding of the disease pathology to aid in identification of new therapeutic targets. Although the diseases covered in this article are diverse and require specific approaches, several high-level, overarching key lessons can be learned by evaluating the strengths, weaknesses and gaps in the available models. This Review is intended to help guide current and future researchers toward successful development of therapeutics in these areas of high unmet medical need.

Indexed as

Bronchopulmonary DysplasiaEnterocolitis, NecrotizingInfant, Newborn, DiseasesDrug DevelopmentHumansInfant, NewbornDrug developmentNeonatalNonclinical

Identifiers

PMID35466995
PMCPMC9066504
OpenAlexW4224311387

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.