Dose range finding TK study (DRF) is usually performed after the PK study, with the aim to pre-select the dose of the drug leading to the appearance of one of the specific manifestations of toxicity – MTD. Dose range finding is performed using repeated dose treatment with the administration route which will later be used for the therapy. On average, 32 animals and 40 working days are required for this study. Blood microsampling procedures are available for reduce animal number. A customized DRF design is also available.
Adverse effects investigation:
– Observations of clinical signs of toxicity
– Hematology – detailed blood analysis, with an assessment of the main leukocyte populations
– Clinical chemistry – wide range of biochemical parameters of blood, urine, and/or other biological fluids
– Behavior tests.
– Metabolic values
– Customized parameters
Deliverable: A detailed study report including full description of the study design, analytical method development, as well as calculations of all common PK and toxicology study parameters. Raw experimental data are available upon request.
Sample Submission. Dry compound or compound in a pre-made animal dosing formulation. Amount depends on the dosing levels. For example, for an acute toxicology study in the group of 30 mice at 10 mg/kg, approximately 10 mg of a compound is required.