Introduction to a manuscript series on the characterization and use of microphysiological systems (MPS) in pharmaceutical safety and ADME applications
Abstract
Opportunities in the drug discovery/development process for potential MPS incorporation.
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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”
From Performance assessment and economic analysis of a human Liver-Chip for predictive toxicology (2022) · cites this paper as [18]
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”
From Performance assessment and economic analysis of a human Liver-Chip for predictive toxicology (2022) · cites this paper as [18]
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Self-citationPerformance assessment and economic analysis of a human Liver-Chip for predictive toxicology
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Self-citationMicrophysiological Systems Evaluation: Experience of TEX-VAL Tissue Chip Testing Consortium
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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
- Publisher
- Royal Society of Chemistry (RSC)
- 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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