Using historical control data in bioassays for regulatory toxicology
Research output: Contribution to journal › Review › Research › peer-review
Documents
- Fulltext
Final published version, 5.07 MB, PDF document
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 language | English |
---|---|
Article number | 105024 |
Journal | Regulatory Toxicology and Pharmacology |
Volume | 125 |
Number of pages | 16 |
ISSN | 0273-2300 |
DOIs | |
Publication status | Published - 2021 |
Bibliographical note
Publisher Copyright:
© 2021 The Author(s)
- Biological relevance, Compatibility intervals, Hazard characterisation, Hazard identification, Historical control data, Relevance thresholds
Research areas
ID: 279762211