人体细胞突变分析作为体内致突变性评估的体外替代方案-猫眼课题宝

人体细胞突变分析作为体内致突变性评估的体外替代方案

批准号：

10696867

负责人：

LESLIE RECIO

金额：

$91.03万

依托单位：

SCITOVATION, LLC

依托单位国家：

美国

项目类别：

财政年份：

2023

资助国家：

美国

项目状态：

未结题

起止时间：

2023-05-23 至 2025-04-30

来源：

https://reporter.nih.gov/project-details/10696867

关键词：

Amendment Animal Testing Animals Biological Assay Cell Cycle Cell Line Cells Chemicals Chromosome abnormality Client Congenital Abnormality Cosmetics DNA DNA Damage Data Detection Development Enzymes European Union Event Food Additives Gene Mutation Genetic Genome Goals Hazard Identification Hepatocyte Heritability Human Human Cell Line Human Genome In Vitro Induced Mutation Liver Mammalian Cell Measures Metabolic Methodology Methods Modeling Mutagenicity Tests Mutagens Mutation Mutation Fixation Nature Pesticides Pharmaceutical Preparations Pharmacologic Substance Phase Poison Public Health Risk Assessment Rodent Sales Scheme Small Business Innovation Research Grant System Techniques Test Result Testing Time Toxic effect Toxicity Tests Toxicogenetics Toxicology Transgenic Organisms Validation Vision analytical method carcinogenesis cost daughter cell dosimetry drug candidate environmental chemical experimental study follow-up genotoxicity improved in vitro Assay in vitro testing in vivo innovation micronucleus mutation assay nervous system disorder new technology next generation next generation sequencing novel strategies novel therapeutics response safety assessment screening success transmission process validation studies

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PROJECT SUMMARY Mutations are heritable changes in the cellular genome and are key events in the induction of cancer, birth defects, and neurological diseases. The lack of a mutagenicity bioassay in human cells is a major data gap in the genetic toxicology test battery used by regulatory agencies for hazard identification and quantitative risk assessments. ScitoVation is developing a New Approach Methodologies (NAMs) combining human cells and Error Corrected Next Generation Sequencing as an in vitro alternative to current regulatory mammalian cell mutagenicity assessment using rodent cell lines, and as an in vitro alternative to in vivo mutation assays.

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