Recommendations for conducting the rodent erythrocyte Pig‐a assay: A report from the HESI GTTC Pig‐a Workgroup

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 nu...

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Detalles Bibliográficos
Autores principales: Dertinger, Stephen D., Bhalli, Javed A., Roberts, Daniel J., Stankowski, Leon F., Gollapudi, B. Bhaskar, Lovell, David P., Recio, Leslie, Kimoto, Takafumi, Miura, Daishiro, Heflich, Robert H.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons, Inc. 2021
Materias:
Review
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7986863/
https://www.ncbi.nlm.nih.gov/pubmed/33608913
http://dx.doi.org/10.1002/em.22427
Descripción
Sumario: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.

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