US FDA GLP Toxicology Laboratory needed for GLP Toxicology Testing: Mammalian Toxicology Assays 1) 14 Day Repeat Dose Comet Study in Rats
- 5 rats/group, males only; 2 dose groups, vehicle and positive controls (20 rats total)
- Daily dosing for 14 days
- Formulations prepared weekly
- Harvest 4 hours after last dose administration
- Collect stomach,kidney,&liver for Comet analysis
2) Toxicokinetic Sample Draw
- Main study rats
- Collect, process and ship plasma for analysis
5 ratstgroup/time point (2 time points)
- 30 total samples
3) In Vivo Micronucleus Assay Scoring of Rodent Peripheral Blood by Flow Cytometry
- Samples collected at terminal sacrifice, 20,000 cells scored per sample, 20total samples
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