Scenario
A pharmaceutical company is investigating in a new drug for the treatment of chronic pain. A single dose 'first into man' study has been completed and a 4-day study in patients with chronic pain is about to start.
The toxicologist telephones because she has just received some results from a 3-month toxicology studies in rats and dogs (Table 3).
The company had previously conducted 28-day studies in the same species.
Now answer the questions associated with this case study.
Table 3 Results of the toxicology studies. These studies are usually dosed as mg/kg but the comparison to humans is usually based on exposure (AUC and Cmax). Consider that the low dose in these studies approximates to the drug exposure in humans following a standard dose, the medium dose is 3 times higher than human exposure and the high dose is approximately 10 times human exposure.
