Elements and development processes for test methods in toxicology and human health-relevant life science research

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2024
Autor:innen
Dipalo, Michele
Schäfer, Jasmin
Kraushaar, Udo
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European Union (EU): 101057014
European Union (EU): 964518
European Union (EU): 964537
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TOX-Free Toxicity assessment on neurons and cardiomyocytes by means of FluoRescence Emitting Electrodes
PARC: Partnership for the Assessment of Risks from Chemicals
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Open Access Gold
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Alternatives to Animal Experimentation : ALTEX. Springer. 2024, 41(1), pp. 142-148. ISSN 1868-596X. eISSN 1868-8551. Available under: doi: 10.14573/altex.2401041
Zusammenfassung

Many laboratory procedures generate data on properties of chemicals, but they cannot be equated with toxicological “test methods”. This apparent discrepancy is not limited to in vitro testing, using animal-free new approach methods (NAM), but also applies to animal-based testing approaches. Here, we give a brief overview of the differences between data generation and the setup or use of a complete test method. While there is excellent literature available on this topic for specialists (GIVIMP guidance; ToxTemp overview), a brief overview and easily-accessible entry point may be useful for a broader community. We provide a single figure to summarize all test method elements and processes required in the development (setup and adaptation) of a test method. The exposure scheme, the endpoint, and the test system are briefly outlined as fundamental elements of any test method. A rationale is provided, why they are not sufficient. We then explain the importance and role of purpose definition (including some information on what is modelled) and the prediction model, aka data interpretation procedure, which depends on the purpose definition, as further essential elements. This connection exemplifies that all fundamental elements are interdependent, and none can be omitted. Finally, discussion is provided on validation as a measure to provide confidence in the reliability, performance, and relevance of a test method. In this sense, validation may be considered a sixth fundamental element for practical use of test methods.

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570 Biowissenschaften, Biologie
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ISO 690CÖLLEN, Eike, Yaroslav TANASKOV, Anna-Katharina HOLZER, Michele DIPALO, Jasmin SCHÄFER, Udo KRAUSHAAR, Marcel LEIST, 2024. Elements and development processes for test methods in toxicology and human health-relevant life science research. In: Alternatives to Animal Experimentation : ALTEX. Springer. 2024, 41(1), pp. 142-148. ISSN 1868-596X. eISSN 1868-8551. Available under: doi: 10.14573/altex.2401041
BibTex
@article{Collen2024Eleme-69318,
  year={2024},
  doi={10.14573/altex.2401041},
  title={Elements and development processes for test methods in toxicology and human health-relevant life science research},
  number={1},
  volume={41},
  issn={1868-596X},
  journal={Alternatives to Animal Experimentation : ALTEX},
  pages={142--148},
  author={Cöllen, Eike and Tanaskov, Yaroslav and Holzer, Anna-Katharina and Dipalo, Michele and Schäfer, Jasmin and Kraushaar, Udo and Leist, Marcel}
}
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