Use compatibility intervals in regulatory toxicology.

Use compatibility intervals in regulatory toxicology.
Regul Toxicol Pharmacol. 2020 Jul 06;:104720
Authors: Hothorn LA, Ralph Pirow
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.
PMID: 32645430 [PubMed - as supplied by publisher]

Source: Regulatory Toxicology and Pharmacology : RTP - July 5, 2020 Category: Toxicology Authors: Hothorn LA, Ralph Pirow Tags: Regul Toxicol Pharmacol Source Type: research