Statistics in Toxicology Using R

Chapter 1

Principles

1.1 Evaluation of short-term repeated toxicity studies

The principles of design and evaluation are discussed in the following by means of selected items in short-term repeated toxicity studies. The aim of repeated dose toxicity studies is to characterize the toxicological profile of a compound usually administered between 4 weeks [283] and 3 months [284]. Although baseline values or data of a recovery period are available in some studies, the typical data are multiple endpoints at the end of the administration period, such as continuous endpoints (e.g., hemoglobin), rates (e.g., proportions of histopathological findings), or ordered categorical data (e.g., graded histopathological findings). The standard design uses a negative ...