24 123 10.3 48 317 26.4 Estimated 3 3.4 0.3 ♂ values for carcinogenicity 7.5 11 0.9 study based on values from 18.75 28 2.3 (B6C3F1) 3 13.2 1.2 ♀ 7.5 38 3.2 18.75 97 8.1 Rat 26 weeks 3 14.6 1.2 Study: S0##C3R100^ 12 69.6 5.8 (Slc:SD) 48 272 23 3 months 3 17 1.4 Study: S0##S2R10A^ 12 73.8 6.2 study 24 198 17 (F344/DuCrj) day 91 – 3 months 48 357 30 Study: S0##S2R10B^ 75 623 52 (F344/DuCrj) day 91 150 1184 99 – Dog 3 months 5 2.6 0.2 Study: S0##S2D100^ 20 27 2.3 (HRP Beagle) – day 90 80 471 39 12 months 5 4.6 0.4 S0##C4D100^ 15 35.3 2.9 (CSK Beagle) – day 365 45 484 40 Human steady state [120 mg] 12 – (healthy subjects) # = animal: human plasma AUC0–24 h; ^Mean male and female AUC values; bolded and shaded = NOAEL.
24 123 10.3 48 317 26.4 Estimated values for carcinogenicity study based on values from (B6C3F1) ♂ 3 3.4 0.3 7.5 11 0.9 18.75 28 2.3 ♀ 3 13.2 1.2 7.5 38 3.2 18.75 97 8.1 Rat 26 weeks Study: S0##C3R100^ (Slc:SD) 3 14.6 1.2 12 69.6 5.8 48 272 23 3 months Study: S0##S2R10A^ study (F344/DuCrj) – day 91 3 17 1.4 12 73.8 6.2 24 198 17 3 months Study: S0##S2R10B^ (F344/DuCrj) – day 91 48 357 30 75 623 52 150 1184 99 Dog 3 months Study: S0##S2D100^ (HRP Beagle) – day 90 5 2.6 0.2 20 27 2.3 80 471 39 12 months S0##C4D100^ (CSK Beagle) – day 365 5 4.6 0.4 15 35.3 2.9 45 484 40 Human (healthy subjects) steady state [120 mg] 12 – # = animal: human plasma AUC0–24 h; ^Mean male and female AUC values; bolded and shaded = NOAEL.
auspar-febuxostat-150108.docx