Evidence map›Paper›PMID 38898799›Full record

ArticleALTEX2024

Trust your gut: Establishing confidence in gastrointestinal models - An overview of the state of the science and contexts of use.

Susan Debad, David Allen, Omari Bandele, Colin Bishop, Michaela Blaylock, Paul Brown, Maureen K Bunger, Julia Y Co, Lynn Crosby, Amber B Daniel and 33 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in ALTEX, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. 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

43 authors.

Susan DebadSJD Consulting LLC, Ijamsville, MD, USA.
David AllenInotiv, Inc., RTP, NC, USA.
Omari BandeleCenter for Food Safety and Applied Nutrition, College Park, MD, USA.
Colin BishopWake Forest Institute for Regenerative Medicine, Winston Salem, NC, USA.
Michaela BlaylockInotiv, Inc., RTP, NC, USA.
Paul BrownCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Maureen K BungerAltis Biosystems, Inc. Research Triangle Park, NC, USA.
Julia Y CoComplex in vitro Systems, Genentech Inc, South San Francisco, CA, USA.
Lynn CrosbyCenter for Food Safety and Applied Nutrition, College Park, MD, USA.
Amber B DanielInotiv, Inc., RTP, NC, USA.
Steve S FergusonMechanistic Toxicology Branch, Division of Translational Toxicology, NIEHS, National Institutes of Health, Bethesda, MD, USA.
Kevin FordOffice of Clinical Pharmacology, US Food and Drug Administration, Silver Spring, MD, USA.
Gonçalo Gamboa da CostaFDA National Center for Toxicological Research, US Food and Drug Administration, Jefferson, AR, USA.
Kristin H Gilchrist4D Bio³ Center for Biotechnology, Uniformed Services University, Bethesda, MD, USA.
Matthew W Grogg711th Human Performance Wing, Air Force Research Laboratory, Wright-Patterson AFB, OH, USA.
Maureen GwinnU.S. Environmental Protection Agency, Office of Research and Development, RTP, NC, USA.
Thomas HartungJohns Hopkins University, Bloomberg School of Public Health and Whiting School of Engineering, Doerenkamp-Zbinden-Chair for Evidence-based Toxicology, Center for Alternatives to Animal Testing (CAAT), Baltimore, MD, USA.
Simon P HoganMary H. Weiser Food Allergy Center, Department of Pathology, Michigan Medicine, University of Michigan, Ann Arbor, MI, USA.
Ye Eun JeongDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
George En KassEuropean Food Safety Authority, Parma, Italy.
Elaina KenyonU.S. Environmental Protection Agency, Office of Research and Development, RTP, NC, USA.
Nicole C KleinstreuerNIEHS/NICEATM, RTP, NC, USA.
Ville KujalaEmulate Inc., Boston, MA, USA.
Patrik LundquistDepartment of Pharmacy, Uppsala University, Uppsala, Sweden.
Joanna MathesonU.S. Consumer Product Safety Commission, Rockville, MD, USA.
Shaun D McCulloughExposure and Protection, RTI International, Durham, NC, USA.
Angela Melton-CelsaDepartment of Microbiology and Immunology, Uniformed Services University, Bethesda, MD, USA.
Steven MusserCenter for Food Safety and Applied Nutrition, College Park, MD, USA.
Ilung OhToxicology Research Division, Ministry of Food and Drug Safety, National Institute of Food and Drug Safety Evaluation, Republic of Korea.
Oluwakemi B OyetadeInotiv, Inc., RTP, NC, USA.
Sarita U PatilDivisions of Allergy and Clinical Immunology, Departments of Medicine and Pediatrics, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Elijah J PetersenBiosystems and Biomaterials Division, National Institute of Standards and Technology, Gaithersburg, MD, USA.
Nakissa SadriehCenter for Food Safety and Applied Nutrition, College Park, MD, USA.
Christie M SayesDepartment of Environmental Science, Baylor University, Waco, TX, USA.
Benjamin S ScruggsAltis Biosystems, Inc. Research Triangle Park, NC, USA.
Yu-Mei TanU.S. Environmental Protection Agency, Office of Pesticide Programs, Research Triangle Park, NC, USA.
Bill ThelinAltis Biosystems, Inc. Research Triangle Park, NC, USA.
M Tyler Nelson711th Human Performance Wing, Air Force Research Laboratory, Wright-Patterson AFB, OH, USA.
José V TarazonaSpanish National Environmental Health Centre, Instituto de Salud Carlos III. Madrid, Spain.
John F WambaughU.S. Environmental Protection Agency, Office of Research and Development, RTP, NC, USA.
Jun-Young YangToxicology Research Division, Ministry of Food and Drug Safety, National Institute of Food and Drug Safety Evaluation, Cheongju, Republic of Korea.
Changwoo YuToxicology Research Division, Ministry of Food and Drug Safety, National Institute of Food and Drug Safety Evaluation, Cheongju, Republic of Korea.
Suzanne FitzpatrickCenter for Food Safety and Applied Nutrition, College Park, MD, USA.

Funding

Safe and Sustainable Alternatives Research ProgramZIAES103381 · NIEHS · NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES · PI FERGUSON, STEPHEN · 2022 to 2025
$7.0M
Intramural EPA EPA999999NIEHS NIH HHS HHSN273201500010C
6 · The paper itself

Abstract

The webinar series and workshop titled “Trust Your Gut: Establishing Confidence in Gastrointestinal Models – An Overview of the State of the Science and Contexts of Use” was co-organized by NICEATM, NIEHS, FDA, EPA, CPSC, DoD, and the Johns Hopkins Center for Alternatives to Animal Testing (CAAT) and hosted at the National Institutes of Health in Bethesda, MD, USA on October 11-12, 2023. New approach methods (NAMs) for assessing issues of gastrointestinal tract (GIT)- related toxicity offer promise in addressing some of the limitations associated with animal-based assessments. GIT NAMs vary in complexity, from two-dimensional monolayer cell line-based systems to sophisticated 3-dimensional organoid systems derived from human primary cells. Despite advances in GIT NAMs, challenges remain in fully replicating the complex interactions and pro­cesses occurring within the human GIT. Presentations and discussions addressed regulatory needs, challenges, and innovations in incorporating NAMs into risk assessment frameworks; explored the state of the science in using NAMs for evaluating systemic toxicity, understanding absorption and pharmacokinetics, evaluating GIT toxicity, and assessing potential allergenicity; and discussed strengths, limitations, and data gaps of GIT NAMs as well as steps needed to establish confidence in these models for use in the regulatory setting.

Indexed as

Animal Testing AlternativesGastrointestinal TractAnimalsHumansModels, BiologicalRisk AssessmentToxicity Tests

Identifiers

PMID38898799
PMCPMC11413798

What OpenQuestion holds

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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.