Cited by 1163D Printing in Biomedical ResearchAnimal testing and alternativesTissue Engineering and Regenerative Medicine

Introduction to a manuscript series on the characterization and use of microphysiological systems (MPS) in pharmaceutical safety and ADME applications

Fabre, Kristin, Berridge, Brian, Proctor, William R., Ralston, Sherry, Will, Yvonne, Baran, Szczepan W., Yoder, Gorm, Van Vleet, Terry R.·2020·Lab on a Chip

Abstract

Opportunities in the drug discovery/development process for potential MPS incorporation.

Integrity signals

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Crossref · 10.1039/c9lc01168d

Cites

9 of 9 references verified0 citation errors · 0 not checkable

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  • The IQ MPS affiliate has provided guidelines for qualifying new models for specific contexts of use to help advance regulatory acceptance and broader industrial adoption.

    “Recognizing the promise of MPS for drug research and development, the IQ MPS affiliate has provided guidelines for qualifying new models for specific contexts of use to help advance regulatory acceptance and broader industrial adoption18”
  • The IQ guidelines for assessment of an in vitro liver MPS within the DILI prediction context of use require evidence that the model replicates key histological structures and functions of the liver and can distinguish between 7 pairs of small-molecule toxic drugs and their non-toxic structural analogs; if it passes, it must demonstrate ability to predict the clinical responses of 6 additional-seed

    “The IQ guidelines for assessment of an in vitro liver MPS within the DILI prediction context of use requires evidence that the model replicates key histological structures and functions of the liver; furthermore, the model must be able to distinguish between 7 pairs of small-molecule toxic drugs and their non-toxic structural analogs. If the model passes through these hurdles, it must demonstrate”

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Authors
Fabre, K., Berridge, B., Proctor, W. R., Ralston, S., Will, Y., Baran, S. W., Yoder, G., & Van Vleet, T. R.
Affiliations
  • Translational Research Institute (AU)
  • National Institute of Environmental Health Sciences (US)
  • Genentech (US)
  • AbbVie (United States) (US)
  • Discovery, Product Development & Supply
  • Novartis (Switzerland) (CH)
  • Janssen Research & Development (United States) (US)
  • Department of Preclinical Safety
Venue
Lab on a Chip
Published
2020
Volume
20
Issue
6
Pages
1049-1057
ISSN
  • 1473-0189 (ISSN-L)
  • 1473-0197
OpenAlex
W3005321388
Cited by
116
References
9
Citations by year
2026: 14 · 2025: 17 · 2024: 23 · 2023: 18 · 2022: 18 · 2021: 23 · 2020: 3
FWCI
4.87
Type
journal article
Language
en
Open access
closed
Locations
  • Lab on a Chip (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Physical Sciences › Engineering › Biomedical Engineering › 3D Printing in Biomedical Research
  • Health Sciences › Veterinary › Small Animals › Animal testing and alternatives
  • Health Sciences › Medicine › Surgery › Tissue Engineering and Regenerative Medicine
Keywords
microphysiological systems, organotypic models, drug safety assessment, ADME, toxicology, organ-on-a-chip, biologics, drug disposition, animal-to-human translation
MeSH terms
Animals, Blood-Brain Barrier, Pharmaceutical Preparations, Humans, Kidney, Liver, Lung

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