Acute toxicity study is usually conducted after the DRF study with the aim to confirm that the specific dose (MTD, or NOAEL) does not lead to the manifestation of pathology-specific side effects. The study is performed using a single treatment with administration route which will later be used for the therapy. The study design includes 1-3 tested doses per route in animals of both sexes, 10 animals in total per each group/dose. Standard study design includes 2 doses, 1 route of administration, mice of both sexes, and a vehicle dosed control group. On average, 30 animals and 15 working days are required for this study. A customized design is also available.
Pathology-specific side effects investigation:
– observations of clinical signs of toxicity
– clinical chemistry
– metabolic values
– customized parameters