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A note on statistical analysis of organ weights in non-clinical toxicological studies.

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A note on statistical analysis of organ weights in non-clinical toxicological studies. / Wolfsegger, Martin J.; Jaki, Thomas; Dietrich, Barbara et al.
In: Toxicology and Applied Pharmacology, Vol. 240, No. 1, 10.2009, p. 117-122.

Research output: Contribution to Journal/MagazineJournal articlepeer-review

Harvard

Wolfsegger, MJ, Jaki, T, Dietrich, B, Kunzler, JA & Barker, K 2009, 'A note on statistical analysis of organ weights in non-clinical toxicological studies.', Toxicology and Applied Pharmacology, vol. 240, no. 1, pp. 117-122. https://doi.org/10.1016/j.taap.2009.06.012

APA

Wolfsegger, M. J., Jaki, T., Dietrich, B., Kunzler, J. A., & Barker, K. (2009). A note on statistical analysis of organ weights in non-clinical toxicological studies. Toxicology and Applied Pharmacology, 240(1), 117-122. https://doi.org/10.1016/j.taap.2009.06.012

Vancouver

Wolfsegger MJ, Jaki T, Dietrich B, Kunzler JA, Barker K. A note on statistical analysis of organ weights in non-clinical toxicological studies. Toxicology and Applied Pharmacology. 2009 Oct;240(1):117-122. doi: 10.1016/j.taap.2009.06.012

Author

Wolfsegger, Martin J. ; Jaki, Thomas ; Dietrich, Barbara et al. / A note on statistical analysis of organ weights in non-clinical toxicological studies. In: Toxicology and Applied Pharmacology. 2009 ; Vol. 240, No. 1. pp. 117-122.

Bibtex

@article{dd125034b5354b839a956417324c5c99,
title = "A note on statistical analysis of organ weights in non-clinical toxicological studies.",
abstract = "Statistical comparison of organ weights between treated and untreated animals have traditionally been used to predict potential toxicity for patients. The manner of presentation of organ weight data, and the value of statistical analyses have been topics of discussion. Historically, a decision tree approach has been applied for statistical comparison of organ weights which does not control the overall error rate and can lead to different statistical tests being used by chance for identical settings causing confusion. This paper proposes a simple nonparametric approach for assessing treatment effects on organ weights in terms of ratios based on the Hodges-Lehmann estimator. This allows for simple interpretation of results and aids in the identification of potential target organs as the evaluation is based on effect sizes and not on p-values allowing a robust proof of effect as well as a robust proof of no effect. The proposed estimate and the corresponding nonparametric confidence interval applied to a rank-sum score can be used as a confirmatory test for difference and as a confirmatory test for equivalence. Exploratory analyses can be performed calculating the proposed estimates for each organ weight separately to be summarized graphically in a confidence interval plot.",
keywords = "Toxicity evaluation method, Risk assessment, Drug toxicity, Organ weights",
author = "Wolfsegger, {Martin J.} and Thomas Jaki and Barbara Dietrich and Kunzler, {Jackie A.} and Kerry Barker",
year = "2009",
month = oct,
doi = "10.1016/j.taap.2009.06.012",
language = "English",
volume = "240",
pages = "117--122",
journal = "Toxicology and Applied Pharmacology",
issn = "1096-0333",
publisher = "Academic Press Inc.",
number = "1",

}

RIS

TY - JOUR

T1 - A note on statistical analysis of organ weights in non-clinical toxicological studies.

AU - Wolfsegger, Martin J.

AU - Jaki, Thomas

AU - Dietrich, Barbara

AU - Kunzler, Jackie A.

AU - Barker, Kerry

PY - 2009/10

Y1 - 2009/10

N2 - Statistical comparison of organ weights between treated and untreated animals have traditionally been used to predict potential toxicity for patients. The manner of presentation of organ weight data, and the value of statistical analyses have been topics of discussion. Historically, a decision tree approach has been applied for statistical comparison of organ weights which does not control the overall error rate and can lead to different statistical tests being used by chance for identical settings causing confusion. This paper proposes a simple nonparametric approach for assessing treatment effects on organ weights in terms of ratios based on the Hodges-Lehmann estimator. This allows for simple interpretation of results and aids in the identification of potential target organs as the evaluation is based on effect sizes and not on p-values allowing a robust proof of effect as well as a robust proof of no effect. The proposed estimate and the corresponding nonparametric confidence interval applied to a rank-sum score can be used as a confirmatory test for difference and as a confirmatory test for equivalence. Exploratory analyses can be performed calculating the proposed estimates for each organ weight separately to be summarized graphically in a confidence interval plot.

AB - Statistical comparison of organ weights between treated and untreated animals have traditionally been used to predict potential toxicity for patients. The manner of presentation of organ weight data, and the value of statistical analyses have been topics of discussion. Historically, a decision tree approach has been applied for statistical comparison of organ weights which does not control the overall error rate and can lead to different statistical tests being used by chance for identical settings causing confusion. This paper proposes a simple nonparametric approach for assessing treatment effects on organ weights in terms of ratios based on the Hodges-Lehmann estimator. This allows for simple interpretation of results and aids in the identification of potential target organs as the evaluation is based on effect sizes and not on p-values allowing a robust proof of effect as well as a robust proof of no effect. The proposed estimate and the corresponding nonparametric confidence interval applied to a rank-sum score can be used as a confirmatory test for difference and as a confirmatory test for equivalence. Exploratory analyses can be performed calculating the proposed estimates for each organ weight separately to be summarized graphically in a confidence interval plot.

KW - Toxicity evaluation method

KW - Risk assessment

KW - Drug toxicity

KW - Organ weights

U2 - 10.1016/j.taap.2009.06.012

DO - 10.1016/j.taap.2009.06.012

M3 - Journal article

VL - 240

SP - 117

EP - 122

JO - Toxicology and Applied Pharmacology

JF - Toxicology and Applied Pharmacology

SN - 1096-0333

IS - 1

ER -