Toxicokinetics study is usually performed after the DRF study, with the aim to find the specific dose (MTD, or NOAEL). The study is carried out using 28-day repeated-dose treatment with the administration route which will later be used for the therapy. The study design includes 3 tested doses per route in animals of both sexes, 10 animals per each group. Standard study design includes 1 route of administration, mice of both sexes, and a vehicle dosed control group. On average, 128 animals and 45 working days are required for this study. A customized TK 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.