Are In Vitro Tests Suitable for Regulatory Use?
Abstract
"All models are wrong, some models are useful." George E.P. Box, "Robustness in the strategy of scientific model building", 1979. This quote from George Box was the title of a book chapter on mathematical models-exactly the type of models which we will not address here, although a lot of the general reasoning can as well be translated to them, especially because they depend on the input and thus on the limitations of either in vitro or in vivo data, when applied for regulatory toxicology. This article was prompted by the 2008 SOT/EuroTox debate (March 2008 in Seattle and October 2008 in Rhodes), which challenged us in an Hegelian approach as thesis and antithesis to present with changing roles on both occasions on the statement "In vitro tests are useless for regulatory use." Here, we would like following Hegel a summary of thesis and antithesis, but also try to outline the synthesis.
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Animal studies remain the gold standard for preclinical study.
“and this remains the gold standard for preclinical study.3,4)”
From Cryopreservation of Hepatocyte Organoid-Derived Cells Generated from Human iPS Cells (2025) · cites this paper as [4]
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References 54 · Cited by 202
- Authors
- Hartung, T., & Daston, G.
- Affiliations
- University of Konstanz (DE)
- ORCID
- Daston, George
- Venue
- Toxicological Sciences
- Publisher
- Oxford University Press (OUP)
- Published
- 2009-07-17
- Volume
- 111
- Issue
- 2
- Pages
- 233-237
- ISSN
- 1096-0929 (ISSN-L)
- 1096-6080
- OpenAlex
- W1995013024
- Cited by
- 202
- References
- 54
- Citations by year
- 2026: 3 · 2025: 8 · 2024: 11 · 2023: 13 · 2022: 8 · 2021: 15 · 2020: 12 · 2019: 17 · 2018: 15 · 2017: 10 · 2016: 12 · 2015: 19 · 2014: 9 · 2013: 9 · 2012: 9
- FWCI
- 20.72
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Toxicological Sciences (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Procter and Gamble
- European Commission
- Topics
- Health Sciences › Veterinary › Small Animals › Animal testing and alternatives
- Life Sciences › Immunology and Microbiology › Immunology › Immunotoxicology and immune responses
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Carcinogens and Genotoxicity Assessment
- Keywords
- in vitro evaluation, regulatory toxicology, in vitro-in vivo extrapolation, model robustness, in vitro-in vivo correlation
- MeSH terms
- Animals, Toxicity Tests, Models, Animal, In Vitro Techniques
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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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