Repeated dose toxicity study

Repeated dose toxicity study is usually conducted with the aim to determine the specific dose (MTD, or NOAEL) after repeated dosage. Treatment design and duration both depend on a therapeutic treatment schedule. The study design includes 1-3 tested doses per route in animals of both sexes, 6-10 animals per group. On average, 30 animals and 30 working days are required for this study. A customized design is also available.

Pathology-specific side effects investigation:

  • observations of clinical signs of toxicity
  • hematology
  • clinical chemistry
  • behavior
  • metabolic values
  • customized parameters.

Deliverable: A  detailed study report including a full description of study design, analytical method development, calculations of all  PK parameters, and PK graphs. Raw experimental data are available upon request.

Sample Submission: Dry compound or compound in a pre-made animal dosing formulation. Amounts depend on the dosing levels. For acute toxicology study in the group of 30 mice at 10 mg/kg, approximately 10 mg of a compound is required.