Trust Your Gut: Establishing Confidence in Gastrointestinal Models

An Overview of the State of the Science and Contexts of Use
Webinar Series & Workshop

Translucent human torso with digestive tract highlighted

Webinar Series:

  • Webinar 1 – Absorption and Pharmacokinetics: September 18, 2023
  • Webinar 2 – Microbiome Effects on Toxicity: September 20, 2023
  • Webinar 3 – Evaluating Potential Allergenicity: October 6, 2023

Workshop: October 11-12, 2023
Porter Neuroscience Research Center, National Institutes of Health, Bethesda, MD

Slides and video for all webinars and the workshop are available below. 

One of the most common chemical exposure routes is via the gastrointestinal tract (GIT). Orally administered substances are first metabolized by the GIT, and both parent substance and any formed metabolites have the potential to be absorbed through the GIT. During these processes, either or both may damage the GIT. Since toxicity in the GIT can result in systemic toxicity, screening of potential toxicants could provide an efficient way to identify potential systemic toxicants. Even in the absence of toxicity, understanding GIT absorption provides insight into systemic exposure levels that inform the potential for toxicity in other target organs.

While in vivo rodent studies have historically been used for understanding GIT absorption and toxicity, animal models have well-documented anatomical, physiological, and biochemical differences from humans. Mammalian cell culture methods of varying complexity can be used in a variety of applications including rapid response, metabolism/metabolite secretion, and microbiome studies, and generating data for pharmacokinetic modeling. Accordingly, NICEATM, NIEHS, FDA, EPA, CPSC, DoD, the Johns Hopkins Center for Alternatives to Animal Testing, and Unilever organized this workshop on the state of the science for using NAMs to predict GIT absorption and toxicity. A series of three preliminary webinars introduced the three principal topics of the workshop:

  1. De-risking systemic toxicity, understanding absorption/pharmacokinetics;
  2. Gastrointestinal toxicity; and
  3. Evaluating potential allergenicity.

These preliminary webinars laid the foundation for the subsequent in-person workshop where speakers from academia, industry, and regulatory bodies explored the state of the science for absorption and metabolism models, integrating the microbiome, and GIT toxicity models.

Webinar and Workshop Slides

Webinar 1 Slides

Webinar 2 Slides

Webinar 3 Slides

Workshop Slides


Webinar 1 - Absorption and Pharmacokinetics
Webinar 2 – Microbiome Effects on Toxicity
Webinar 3 – Evaluating Potential Allergenicity
Workshop Day 1
Workshop Day 2