Using historical control data in bioassays for regulatory toxicology

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 effec...

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Bibliographic Details
Published in:Regulatory toxicology and pharmacology 2021-10, Vol.125, p.105024, Article 105024
Main Authors: Kluxen, Felix M., Weber, Klaus, Strupp, Christian, Jensen, Signe M., Hothorn, Ludwig A., Garcin, Jean-Christophe, Hofmann, Thomas
Format: Article
Language:English
Subjects:
Biological Assay - methods
Biological relevance
Compatibility intervals
Databases, Factual
Dose-Response Relationship, Drug
Hazard characterisation
Hazard identification
Historical control data
Relevance thresholds
Risk Assessment
Toxicology - methods
Toxicology - standards
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Summary: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. •Holistic review of historical control data use.•Derivation of historical control data limits or relevance thresholds.•Consideration of uncertainty in toxicological assessments.
ISSN:0273-2300
1096-0295
DOI:10.1016/j.yrtph.2021.105024