Details
| Original language | English |
|---|---|
| Article number | 104720 |
| Journal | Regulatory Toxicology and Pharmacology |
| Volume | 116 |
| Early online date | 6 Jul 2020 |
| Publication status | Published - Oct 2020 |
Abstract
Recently it was recommended to avoid significance tests, in particular dichotomization into significant/non-significant on the basis of a p-value and a fixed 5% significance level (i.e. false positive rate). As an alternative, the interpretation of a suitable effect size and its compatibility interval is recommended, i.e. confidence intervals whose compatibility with the data, the assumptions, and the models is shown. This concept is used for the evaluation of assays in regulatory toxicology with special emphasis on the proof of hazard and proof of safety. Three case studies for multiple endpoints, multiple models and the consideration of historical controls illustrate the applicability of this concept. The corresponding software code for the open-source R project for statistical computing (www.r-project.org) is provided.
Keywords
- Compatibility intervals, Statistics
ASJC Scopus subject areas
- Pharmacology, Toxicology and Pharmaceutics(all)
- Toxicology
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In: Regulatory Toxicology and Pharmacology, Vol. 116, 104720, 10.2020.
Research output: Contribution to journal › Article › Research › peer review
}
TY - JOUR
T1 - Use compatibility intervals in regulatory toxicology
AU - Hothorn, Ludwig A.
AU - Pirow, Ralph
PY - 2020/10
Y1 - 2020/10
N2 - Recently it was recommended to avoid significance tests, in particular dichotomization into significant/non-significant on the basis of a p-value and a fixed 5% significance level (i.e. false positive rate). As an alternative, the interpretation of a suitable effect size and its compatibility interval is recommended, i.e. confidence intervals whose compatibility with the data, the assumptions, and the models is shown. This concept is used for the evaluation of assays in regulatory toxicology with special emphasis on the proof of hazard and proof of safety. Three case studies for multiple endpoints, multiple models and the consideration of historical controls illustrate the applicability of this concept. The corresponding software code for the open-source R project for statistical computing (www.r-project.org) is provided.
AB - Recently it was recommended to avoid significance tests, in particular dichotomization into significant/non-significant on the basis of a p-value and a fixed 5% significance level (i.e. false positive rate). As an alternative, the interpretation of a suitable effect size and its compatibility interval is recommended, i.e. confidence intervals whose compatibility with the data, the assumptions, and the models is shown. This concept is used for the evaluation of assays in regulatory toxicology with special emphasis on the proof of hazard and proof of safety. Three case studies for multiple endpoints, multiple models and the consideration of historical controls illustrate the applicability of this concept. The corresponding software code for the open-source R project for statistical computing (www.r-project.org) is provided.
KW - Compatibility intervals
KW - Statistics
UR - http://www.scopus.com/inward/record.url?scp=85087816628&partnerID=8YFLogxK
U2 - 10.1016/j.yrtph.2020.104720
DO - 10.1016/j.yrtph.2020.104720
M3 - Article
C2 - 32645430
AN - SCOPUS:85087816628
VL - 116
JO - Regulatory Toxicology and Pharmacology
JF - Regulatory Toxicology and Pharmacology
SN - 0273-2300
M1 - 104720
ER -