English to Polish Science Medical (general) farmacja, chemia, patenty

Table 3. Proposed Clinical Starting Dose of Compound A Based on the Severely Toxic Dose in 10% of the Rats and the Highest Non-severely Toxic Dose in the One-Month Toxicity Study in Dogs
Species Rat STD10 or Dog HNSTD (mg base/kg) HED (mg base/kg) HED (mg base/kg) Safety Factor HED/Safety Factor (mg base)" Proposed Clinical Starting Dose (mg base)



Compound A was evaluated in non-GLP exploratory toxicology and genetic toxicology studies, and in GLP repeat-dose (≤4-week nonclinical toxicology) studies. GLP 4-week oral toxicity studies (with a 4-week recovery period) were conducted in rats (0, 5, 10, or 20 mg base/kg/dose for females, and 0, 15, 30, or 60 mg base/kg/dose for males), and Beagle dogs (0, 1.75, 3.75, or 7.5 mg base/kg/dose).