Recommendations on the statistical analysis of the Comet assay

Author:

Bright Jonathan1,Aylott Mike2,Bate Simon3,Geys Helena4,Jarvis Philip1,Saul Jim5,Vonk Richardus6

Affiliation:

1. Discovery Statistics; AstraZeneca R&D; Macclesfield; Cheshire; UK

2. Statistical Sciences Europe; GlaxoSmithKline; Harlow; UK

3. Huntingdon Life Sciences Ltd; Huntingdon; Cambridgeshire; UK

4. Janssen Pharmaceutica; Johnson & Johnson; Beerse; Belgium

5. Covance Laboratories; Harrogate; UK

6. Global Drug Discovery Statistics; Bayer Schering Pharma AG; Berlin; Germany

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Reference19 articles.

1. ICH M3(R2) Nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals 2010

2. ICH S2(R1) Guidance on genotoxicity testing and data interpretation for pharmaceuticals intended for human use 2008

3. Committee on Mutagenicity of Chemicals in Food, Consumer Products and the Environment (COM) Guidance on a Strategy for Genotoxicity Testing of Chemical Substances http://www.iacom.org.uk/guidstate/documents/COMGuidanceFINAL2.pdf 2011

4. Statistical issues in the use of the comet assay;Lovell;Mutagenesis,2008

5. Collaborative study on fifteen compounds in the rat-liver Comet assay integrated into 2- and 4-week repeat-dose studies;Rothfuss;Mutation Research,2010

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