Details
| Original language | English |
|---|---|
| Article number | 105024 |
| Journal | Regulatory Toxicology and Pharmacology |
| Volume | 125 |
| Early online date | 5 Aug 2021 |
| Publication status | Published - Oct 2021 |
Abstract
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.
Keywords
- Biological relevance, Compatibility intervals, Hazard characterisation, Hazard identification, Historical control data, Relevance thresholds
ASJC Scopus subject areas
- Pharmacology, Toxicology and Pharmaceutics(all)
- Toxicology
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In: Regulatory Toxicology and Pharmacology, Vol. 125, 105024, 10.2021.
Research output: Contribution to journal › Review article › Research › peer review
}
TY - JOUR
T1 - Using historical control data in bioassays for regulatory toxicology
AU - Kluxen, Felix M.
AU - Weber, Klaus
AU - Strupp, Christian
AU - Jensen, Signe M.
AU - Hothorn, Ludwig A.
AU - Garcin, Jean Christophe
AU - Hofmann, Thomas
N1 - 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.
PY - 2021/10
Y1 - 2021/10
N2 - 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.
AB - 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.
KW - Biological relevance
KW - Compatibility intervals
KW - Hazard characterisation
KW - Hazard identification
KW - Historical control data
KW - Relevance thresholds
UR - http://www.scopus.com/inward/record.url?scp=85111964200&partnerID=8YFLogxK
U2 - 10.1016/j.yrtph.2021.105024
DO - 10.1016/j.yrtph.2021.105024
M3 - Review article
AN - SCOPUS:85111964200
VL - 125
JO - Regulatory Toxicology and Pharmacology
JF - Regulatory Toxicology and Pharmacology
SN - 0273-2300
M1 - 105024
ER -