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Recommendations on the statistical analysis of the Comet assay
Author(s) -
Bright Jonathan,
Aylott Mike,
Bate Simon,
Geys Helena,
Jarvis Philip,
Saul Jim,
Vonk Richardus
Publication year - 2011
Publication title -
pharmaceutical statistics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.421
H-Index - 38
eISSN - 1539-1612
pISSN - 1539-1604
DOI - 10.1002/pst.530
Subject(s) - comet , log normal distribution , end point , statistical analysis , statistics , computer science , toxicology , econometrics , risk analysis (engineering) , mathematics , medicine , biology , physics , astrophysics , real time computing
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. Copyright © 2011 John Wiley & Sons, Ltd.