Using historical control data in bioassays for regulatory toxicology

Publikation: Bidrag til tidsskrift › Review › Forskning › fagfællebedømt

Standard

Using historical control data in bioassays for regulatory toxicology. / Kluxen, Felix M.; Weber, Klaus; Strupp, Christian; Jensen, Signe M.; Hothorn, Ludwig A.; Garcin, Jean Christophe; Hofmann, Thomas.

I: Regulatory Toxicology and Pharmacology, Bind 125, 105024, 2021.

Publikation: Bidrag til tidsskrift › Review › Forskning › fagfællebedømt

Harvard

Kluxen, FM, Weber, K, Strupp, C, Jensen, SM, Hothorn, LA, Garcin, JC & Hofmann, T 2021, 'Using historical control data in bioassays for regulatory toxicology', Regulatory Toxicology and Pharmacology, bind 125, 105024. https://doi.org/10.1016/j.yrtph.2021.105024

APA

Kluxen, F. M., Weber, K., Strupp, C., Jensen, S. M., Hothorn, L. A., Garcin, J. C., & Hofmann, T. (2021). Using historical control data in bioassays for regulatory toxicology. Regulatory Toxicology and Pharmacology, 125, [105024]. https://doi.org/10.1016/j.yrtph.2021.105024

Vancouver

Kluxen FM, Weber K, Strupp C, Jensen SM, Hothorn LA, Garcin JC o.a. Using historical control data in bioassays for regulatory toxicology. Regulatory Toxicology and Pharmacology. 2021;125. 105024. https://doi.org/10.1016/j.yrtph.2021.105024

Author

Kluxen, Felix M. ; Weber, Klaus ; Strupp, Christian ; Jensen, Signe M. ; Hothorn, Ludwig A. ; Garcin, Jean Christophe ; Hofmann, Thomas. / Using historical control data in bioassays for regulatory toxicology. I: Regulatory Toxicology and Pharmacology. 2021 ; Bind 125.

Bibtex

@article{1785159189f44f8b9243da283771e4a9,

title = "Using historical control data in bioassays for regulatory toxicology",

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",

author = "Kluxen, {Felix M.} and Klaus Weber and Christian Strupp and Jensen, {Signe M.} and Hothorn, {Ludwig A.} and Garcin, {Jean Christophe} and Thomas Hofmann",

note = "Publisher Copyright: {\textcopyright} 2021 The Author(s)",

year = "2021",

doi = "10.1016/j.yrtph.2021.105024",

language = "English",

volume = "125",

journal = "Regulatory Toxicology and Pharmacology",

issn = "0273-2300",

publisher = "Academic Press",

}

RIS

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

PY - 2021

Y1 - 2021

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

U2 - 10.1016/j.yrtph.2021.105024

DO - 10.1016/j.yrtph.2021.105024

M3 - Review

C2 - 34364928

AN - SCOPUS:85111964200

VL - 125

JO - Regulatory Toxicology and Pharmacology

JF - Regulatory Toxicology and Pharmacology

SN - 0273-2300

M1 - 105024

ER -

ID: 279762211