Discussion on statistical analysis of carcinogenicity studies with an early terminated treated group.

High rates of mortality on long term carcinogenicity studies can often result in challenges when it comes to the statistical analysis of tumor incidence. The current regulatory advice often results in treated groups being terminated earlier than the control group. However, this advice rarely considers the impact of this action on the statistical analyses.

The 3D reconstructed skin micronucleus assay: considerations for optimal protocol design.

Implementation of the seventh amendment to the EU Cosmetics Directive has driven much research into suitable in vitro alternative assays to support satisfactory risk assessments. One such assay is the reconstructed skin micronucleus (RSMN) assay. First reported in 2006, further development occurred and a standard protocol was published in 2011.

An assessment of the statistical methods used to analyse toxicology studies.

The Statisticians in the Pharmaceutical Industry Toxicology Special Interest Group has collated and compared statistical analysis methods for a number of toxicology study types including general toxicology, genetic toxicology, safety pharmacology and carcinogenicity. In this paper, we present the study design, experimental units and analysis methods.

Recommendations on the statistical analysis of the Comet assay.

In 2010, the Statisticians in the Pharmaceutical Industry (PSI) Toxicology Special Interest Group met to discuss the design and analysis of the Comet assay. The Comet assay is one potential component of the package of safety studies required by regulatory bodies. As these studies usually involve a three-way nested experimental design and as the distribution of the measured response is usually either lognormal or lognormal plus a point mass at zero, the analysis is not straightforward.

Review of the statistical analysis of the dog telemetry study.

In 2008, the PSI Toxicology Special Interest Group met to discuss the design and analysis of dog telemetry studies. The dog telemetry study is one component of the integrated cardiovascular assessment required by regulatory bodies. Although there are guidelines for these studies, little is said about the statistical analysis.