Dose range finding (DRF) sample analysis
Dose range finding (DRF) sample analysis provides the first stage of toxicology assessments to select doses for subsequent regulatory studies. These studies are then used to determine doses for longer term regulatory studies to assess human and environmental health risks. DRF is conducted using single dose then repeated dose treatment using the intended therapeutic route of administration.
The goal is to establish potential organ toxicity and tolerability by monitoring clinical signs, blood pressure, weight changes or cardiac parameters, depending on the therapy area. Management of animal welfare is important; selecting a dose that is too small or too high risks needing to repeat a study or perform analysis on extra models.
Doses also need to be carefully selected, considering target pharmacology, experience of the test sample and the intended human use.