Using historical control data in bioassays for regulatory toxicology

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  • 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.

Original languageEnglish
Article number105024
JournalRegulatory Toxicology and Pharmacology
Volume125
Number of pages16
ISSN0273-2300
DOIs
Publication statusPublished - 2021

Bibliographical note

Publisher Copyright:
© 2021 The Author(s)

    Research areas

  • Biological relevance, Compatibility intervals, Hazard characterisation, Hazard identification, Historical control data, Relevance thresholds

ID: 279762211