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Using historical control data in bioassays for regulatory toxicology

Publikation: Bidrag til tidsskriftReviewForskningfagfællebedømt

  • Felix M. Kluxen
  • Klaus Weber
  • Christian Strupp
  • Jensen, Signe Marie
  • Ludwig A. Hothorn
  • Jean Christophe Garcin
  • Thomas Hofmann

Historical control data (HCD) consist of pooled control group responses from bioassays. These data must be collected and are often used or reported in regulatory toxicology studies for multiple purposes: as quality assurance for the test system, to help identify toxicological effects and their effect-size relevance and to address the statistical multiple comparison problem. The current manuscript reviews the various classical and potential new approaches for using HCD. Issues in current practice are identified and recommendations for improved use and discussion are provided. Furthermore, stakeholders are invited to discuss whether it is necessary to consider uncertainty when using HCD formally and statistically in toxicological discussions and whether binary inclusion/exclusion criteria for HCD should be revised to a tiered information contribution to assessments. Overall, the critical value of HCD in toxicological bioassays is highlighted when used in a weight-of-evidence assessment.

OriginalsprogEngelsk
Artikelnummer105024
TidsskriftRegulatory Toxicology and Pharmacology
Vol/bind125
ISSN0273-2300
DOI
StatusUdgivet - 2021

Bibliografisk note

Funding Information:
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The research was conducted as scientific expert contribution of the authors of which a subset is affiliated with the industry association CropLife Europe. CropLife Europe finances the publication fees for this article.

Publisher Copyright:
© 2021 The Author(s)

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