| Literature DB >> 33608913 |
Stephen D Dertinger1, Javed A Bhalli2, Daniel J Roberts3, Leon F Stankowski3, B Bhaskar Gollapudi4, David P Lovell5, Leslie Recio6, Takafumi Kimoto7, Daishiro Miura7, Robert H Heflich8.
Abstract
The rodent Pig-a assay is a flow cytometric, phenotype-based method used to measure in vivo somatic cell mutation. An Organization for Economic Co-operation and Development (OECD) test guideline is currently being developed to support routine use of the assay for regulatory purposes (OECD project number 4.93). This article provides advice on best practices for designing and conducting rodent Pig-a studies in support of evaluating test substance safety, with a focus on the rat model. Various aspects of assay conduct, including laboratory proficiency, minimum number of animals per dose group, preferred treatment and blood sampling schedule, and statistical analysis are described.Entities:
Keywords: Pig-a gene; flow cytometry; genotoxicity; mutagen; mutation assay
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Year: 2021 PMID: 33608913 PMCID: PMC7986863 DOI: 10.1002/em.22427
Source DB: PubMed Journal: Environ Mol Mutagen ISSN: 0893-6692 Impact factor: 3.216