Publications

@article{abbas_primary_2025,

title = {A primary human Gut/Liver microphysiological system to estimate human oral bioavailability},

author = {Yassen Abbas and Morné van Wyk and Hailey Sze and James Christophi and Ashley A. Spreen and Robert Jarrett Bliton and Elizabeth M. Boazak and Tomasz Kostrzewski},

url = {https://dmd.aspetjournals.org/article/S0090-9556(25)09139-1/fulltext},

doi = {10.1016/j.dmd.2025.100130},

issn = {0090-9556, 1521-009X},

year  = {2025},

date = {2025-09-01},

urldate = {2025-09-01},

journal = {Drug Metabolism and Disposition},

volume = {53},

number = {9},

note = {Publisher: Elsevier},

keywords = {absorption, Bioavailability, Biopharmaceutics Classification System, Fa, Fg, Gut liver microphysiological system, metabolism, microphysiological system, Organ-on-a-chip, Papp, pharmacokinetic},

pubstate = {published},

tppubtype = {article}

}

@article{debad_trust_2024,

title = {Trust your gut: Establishing confidence in gastrointestinal models – An overview of the state of the science and contexts of use},

author = {Susan Debad and David Allen and Omari Bandele and Colin Bishop and Michaela Blaylock and Paul Brown and Maureen K. Bunger and Julia Y. Co and Lynn Crosby and Amber B. Daniel and Steve S. Ferguson and Kevin Ford and Gonçalo Gamboa da Costa and Kristin H. Gilchrist and Matthew W. Grogg and Maureen Gwinn and Thomas Hartung and Simon P. Hogan and Ye Eun Jeong and George E. N. Kass and Elaina Kenyon and Nicole C. Kleinstreuer and Ville Kujala and Patrik Lundquist and Joanna Matheson and Shaun D. McCullough and Angela Melton-Celsa and Steven Musser and Ilung Oh and Oluwakemi B. Oyetade and Sarita U. Patil and Elijah J. Petersen and Nakissa Sadrieh and Christie M. Sayes and Benjamin S. Scruggs and Yu-Mei Tan and Bill Thelin and M. Tyler Nelson and José V. Tarazona and John F. Wambaugh and Jun-Young Yang and Changwoo Yu and Suzanne Fitzpatrick},

url = {https://altex.org/index.php/altex/article/view/2787},

doi = {10.14573/altex.2403261},

issn = {1868-8551},

year  = {2024},

date = {2024-07-16},

urldate = {2024-07-16},

journal = {ALTEX},

volume = {41},

number = {3},

pages = {402–424},

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. 

Plain language summaryNon-animal methods to assess whether chemicals may be toxic to the human digestive tract promise to complement or improve on animal-based methods. These approaches, which are based on human or animal cells and/or computer models, are faced with their own technical challenges and need to be shown to predict adverse effects in humans. Regulators are tasked with evaluating submitted data to best protect human health and the environment. A webinar series and workshop brought together scientists from academia, industry, military, and regulatory authorities from dif­ferent countries to discuss how non-animal methods can be integrated into the risk assessment of drugs, food additives, dietary supplements, pesticides, and industrial chemicals for gastrointestinal toxicity.},

keywords = {Adverse events, Co-culture model, Enteroendocrine Cells, epithelial barrier, Gut barrier function, Gut liver microphysiological system, in vitro models, intestinal barrier, microphysiological system, microphysiological systems, organ-on-chips},

pubstate = {published},

tppubtype = {article}

}