Publikation:

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

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Datum

2024

Autor:innen

Debad, Susan
Allen, David
Bandele, Omari
Bishop, Colin
Blaylock, Michaela
Brown, David
Bunger, Maureen K.
Co, Julia Y.
Crosby, Lynn
et al.

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Angaben zur Forschungsförderung

European Union (EU): 964537

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Open Access-Veröffentlichung
Open Access Hybrid
Core Facility der Universität Konstanz

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Titel in einer weiteren Sprache

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Published

Erschienen in

ALTEX. ALTEX Edition. 2024, 41(3), S. 402-424. ISSN 1868-596X. eISSN 1868-8551. Verfügbar unter: doi: 10.14573/altex.2403261

Zusammenfassung

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.

Zusammenfassung in einer weiteren Sprache

Fachgebiet (DDC)
570 Biowissenschaften, Biologie

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ISO 690DEBAD, Susan, David ALLEN, Omari BANDELE, Colin BISHOP, Michaela BLAYLOCK, David BROWN, Maureen K. BUNGER, Julia Y. CO, Lynn CROSBY, Thomas HARTUNG, 2024. Trust your gut : Establishing confidence in gastrointestinal models : An overview of the state of the science and contexts of use. In: ALTEX. ALTEX Edition. 2024, 41(3), S. 402-424. ISSN 1868-596X. eISSN 1868-8551. Verfügbar unter: doi: 10.14573/altex.2403261
BibTex
@article{Debad2024Trust-71256,
  year={2024},
  doi={10.14573/altex.2403261},
  title={Trust your gut : Establishing confidence in gastrointestinal models : An overview of the state of the science and contexts of use},
  number={3},
  volume={41},
  issn={1868-596X},
  journal={ALTEX},
  pages={402--424},
  author={Debad, Susan and Allen, David and Bandele, Omari and Bishop, Colin and Blaylock, Michaela and Brown, David and Bunger, Maureen K. and Co, Julia Y. and Crosby, Lynn and Hartung, Thomas}
}
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Interner Vermerk

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