title: Recommendations on the statistical analysis of the Comet assay.
abstract: 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. This has led to many different types of analysis being proposed in the literature, with several different methods applied within the pharmaceutical industry itself. This article summarises the PSI Toxicology Group's discussions and recommendations around these issues.
authors: Discovery Statistics, AstraZeneca R&D, Macclesfield, Cheshire, UK. jonathan.bright@astrazeneca.com
authors: Jonathan
authors: J
authors: Bright
authors: Mike
authors: M
authors: Aylott
authors: Simon
authors: S
authors: Bate
authors: Helena
authors: H
authors: Geys
authors: Philip
authors: P
authors: Jarvis
authors: Jim
authors: J
authors: Saul
authors: Richardus
authors: R
authors: Vonk
mesh_terms: D000818:Animals; D020552:Comet Assay / Q000379:methods / Q000706:statistics & numerical data*; D004345:Drug Industry / Q000706:statistics & numerical data*; D015233:Models, Statistical; D012377:Rodentia