Trust Your Gut: Establishing Confidence in Gastrointestinal Models An Overview of the State of the Science and Contexts of Use

Published

May 15, 2024

Author(s)

Susan Debad, David Allen, Maria Teresa Baltazar, Omari Bandele, Michaela Blaylock, Paul Brown, Maureen Bunger, Julia Co, Lynn Crosby, Amber Daniel, Steven Ferguson, Kevin Ford, Goncalo Gamboa da Costa, Kristin Gilchrist, Matthew Grogg, Maureen Gwinn, Thomas Hartung, Simon Hogan, Ye Jeong, George Kass, Elaina Kenyon, Nicole Kleinstreuer, Ville Kujala, Jaehyun Lim, Patrik Lundquist, Joanna Matheson, Shaun McCullough, Angela Melton-Celsa, Steven Musser, Ilung Oh, Oluwakemi Oyetade, Sarita Patil, Elijah Petersen, Nakissa Sadrieh, Christie Sayes, Benjamin Scruggs, Yu-Mei Tan, Bill Thelin, M. Tyler Nelson, José Tarazona, John Wambaugh, Jun-young Yang, Changwoo Yu, Suzanne Fitzpatrick

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, the Johns Hopkins Center for Alternatives to Animal Testing (CAAT), and Unilever, and hosted at the National Institutes of Health in Bethesda, MD, USA on October 11-12, 2023. New approach methodologies (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 de-risking 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.

Citation

Altex-Alternativen Zu Tier Experimenten

Pub Type

Journals

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Citation

Debad, S. , Allen, D. , Baltazar, M. , Bandele, O. , Blaylock, M. , Brown, P. , Bunger, M. , Co, J. , Crosby, L. , Daniel, A. , Ferguson, S. , Ford, K. , Gamboa da Costa, G. , Gilchrist, K. , Grogg, M. , Gwinn, M. , Hartung, T. , Hogan, S. , Jeong, Y. , Kass, G. , Kenyon, E. , Kleinstreuer, N. , Kujala, V. , Lim, J. , Lundquist, P. , Matheson, J. , McCullough, S. , Melton-Celsa, A. , Musser, S. , Oh, I. , Oyetade, O. , Patil, S. , Petersen, E. , Sadrieh, N. , Sayes, C. , Scruggs, B. , Tan, Y. , Thelin, B. , Nelson, M. , Tarazona, J. , Wambaugh, J. , Yang, J. , Yu, C. and Fitzpatrick, S. (2024), Trust Your Gut: Establishing Confidence in Gastrointestinal Models An Overview of the State of the Science and Contexts of Use, Altex-Alternativen Zu Tier Experimenten, [online], https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=957551 (Accessed October 19, 2024)