Related Experiment Video
Updated: Aug 16, 2026

Screening for Endocrine Activity in Water Using Commercially-available In Vitro Transactivation Bioassays
Published on: December 4, 2016
Selected biostatistical aspects of the validation of in vitro toxicological assays
1Department of Bioinformatics, University of Hannover, 30419 Hannover, Germany.
Abstract:
An overview is presented on selected biostatistical aspects of the validation of in vitro toxicological assays. Primarily, the statistical analysis of single assays is discussed. Several approaches are compared for the possible non-monotonic dose-response relationship with a priori unknown shapes. The use of confidence intervals instead of p values for toxicologically appropriate decision making is explained. New methods are discussed for demonstrating interlaboratory similarity for dose-response designs are discussed. For validation, the inappropriateness of the concordance coefficient is shown, and sensitive and specificity as well as predictive values are proposed as alternatives. The problem of the missing gold standard is highlighted.
Related Concept Videos
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
In Vitro Drug Release Testing: Overview, Development and Validation
Toxicity Testing in Animals

