Combination studies integrate the analysis of multiple endpoints to evaluate the genotoxic risk of a compound. Utilizing a 3-dose protocol design, the in vivo rat bone marrow micronucleus assay, in vivo Comet assay, and flow cytometric peripheral blood micronucleus assay are combined into one protocol. Based on individual assay result data and published literature, the results of multi-endpoint assays are highly predictable for evaluating genotoxic risk.
Key advantages to using multi-endpoint assays include:
- Up to 70% reduction in animals needed for rodent studies
- Obtain more toxicity information in a quicker timeframe
- Less test article required due to need for fewer animals
- Evaluate toxicity in a wide range of tissues