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Guidance for statistical design and analysis of toxicological dose–response experiments, based on a comprehensive literature review.

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Title: Guidance for statistical design and analysis of toxicological dose–response experiments, based on a comprehensive literature review.
Authors: Kappenberg, Franziska1 (AUTHOR) kappenberg@statistik.tu-dortmund.de, Duda, Julia C.1 (AUTHOR), Schürmeyer, Leonie1 (AUTHOR), Gül, Onur1 (AUTHOR), Brecklinghaus, Tim2 (AUTHOR), Hengstler, Jan G.2 (AUTHOR), Schorning, Kirsten1 (AUTHOR), Rahnenführer, Jörg1 (AUTHOR)
Source: Archives of Toxicology. Oct2023, Vol. 97 Issue 10, p2741-2761. 21p.
Subject Terms: *EXPERIMENTAL design, *STATISTICS, *STATISTICAL decision making, *STATISTICAL models, *PUNISHMENT
Abstract: The analysis of dose–response, concentration–response, and time–response relationships is a central component of toxicological research. A major decision with respect to the statistical analysis is whether to consider only the actually measured concentrations or to assume an underlying (parametric) model that allows extrapolation. Recent research suggests the application of modelling approaches for various types of toxicological assays. However, there is a discrepancy between the state of the art in statistical methodological research and published analyses in the toxicological literature. The extent of this gap is quantified in this work using an extensive literature review that considered all dose–response analyses published in three major toxicological journals in 2021. The aspects of the review include biological considerations (type of assay and of exposure), statistical design considerations (number of measured conditions, design, and sample sizes), and statistical analysis considerations (display, analysis goal, statistical testing or modelling method, and alert concentration). Based on the results of this review and the critical assessment of three selected issues in the context of statistical research, concrete guidance for planning, execution, and analysis of dose–response studies from a statistical viewpoint is proposed. [ABSTRACT FROM AUTHOR]
Copyright of Archives of Toxicology is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Guidance for statistical design and analysis of toxicological dose–response experiments, based on a comprehensive literature review.
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  Data: The analysis of dose–response, concentration–response, and time–response relationships is a central component of toxicological research. A major decision with respect to the statistical analysis is whether to consider only the actually measured concentrations or to assume an underlying (parametric) model that allows extrapolation. Recent research suggests the application of modelling approaches for various types of toxicological assays. However, there is a discrepancy between the state of the art in statistical methodological research and published analyses in the toxicological literature. The extent of this gap is quantified in this work using an extensive literature review that considered all dose–response analyses published in three major toxicological journals in 2021. The aspects of the review include biological considerations (type of assay and of exposure), statistical design considerations (number of measured conditions, design, and sample sizes), and statistical analysis considerations (display, analysis goal, statistical testing or modelling method, and alert concentration). Based on the results of this review and the critical assessment of three selected issues in the context of statistical research, concrete guidance for planning, execution, and analysis of dose–response studies from a statistical viewpoint is proposed. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of Archives of Toxicology is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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              Text: Oct2023
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