et al. per week 154 16, 1980] (PO gavage) d 47 Rat (OFA) 102 = 0.49, 2.9, 0.9, – – ♂ weeks 1.37, 5.0; 8.2, 2.5, = 0.60, 30 9.1 ♀ 1.65, 6.19 3.6, 1.1, (diet) 9.9, 3.0, 37.1 11 Rat (OFA) 4 weeks 10 (diet) 60 18 – – Rat (Harlan days 3, 10 (diet) 70.8, 18, 0.4, 5.4, ≤94 SD; [cardiac 213 60 1.3 18 ♂) Rat 5 or 10 7.5 (5 397, 45, 2.4, 14, days days), 2 x 599, 90, 3.7, 27, 7.5 (5 3500 120 22 36 ♂) days), 2 x toxicity; 7.5 (4 days) and then 2 x 10 (6 days) (PO (gavage)) Dog 90 days 1.0, 3.0, 20, 6.1, – – (beagle) 5/10 60, 18, 200 60 toxicity] Dog 1 year 0.3, 1.0, 3.0 6, 1.8, – – (beagle) 20, 6.1, 60 18 toxicity] Human steady [4 mg] 162.1 3.3e – – ADHD state patients (♂ [Clinical + 6–12 ♀), years of age, n = 14, mean weight = 34.7 kg a = animal: human plasma; b = BSA conversion factors for mg/kg to mg/m2: human child (35 kg) = 29, mouse = 3, rat = 6, dog = 20; c = no data available; d = doses adjusted to reflect weekly exposure; e = The 3.3 mg/m2 clinical dose has been calculated for the patient group in Study SPD503-107. Based on the
et al. 1980] per week (PO gavage) 154 d 16, 47 Rat (OFA) 102 weeks ♂ = 0.49, 1.37, 5.0; ♀ = 0.60, 1.65, 6.19 (diet) – 2.9, 8.2, 30 3.6, 9.9, 37.1 – 0.9, 2.5, 9.1 1.1, 3.0, 11 Rat (OFA) 4 weeks 10 (diet) – 60 – 18 Rat (Harlan SD; ♂) ≤94 days [cardiac 3, 10 (diet) 70.8, 213 18, 60 0.4, 1.3 5.4, 18 Rat ♂) 5 or 10 days toxicity; 7.5 (5 days), 2 x 7.5 (5 days), 2 x 7.5 (4 days) and then 2 x 10 (6 days) (PO (gavage)) 397, 599, 3500 45, 90, 120 2.4, 3.7, 22 14, 27, 36 Dog (beagle) 90 days toxicity] 1.0, 3.0, 5/10 – 20, 60, 200 – 6.1, 18, 60 Dog (beagle) 1 year toxicity] 0.3, 1.0, 3.0 – 6, 20, 60 – 1.8, 6.1, 18 Human ADHD patients (♂ + ♀), 6–12 years of age, n = 14, mean weight = 34.7 kg steady state [Clinical [4 mg] 162.1 3.3e – – a = animal: human plasma; b = BSA conversion factors for mg/kg to mg/m2: human child (35 kg) = 29, mouse = 3, rat = 6, dog = 20; c = no data available; d = doses adjusted to reflect weekly exposure; e = The 3.3 mg/m2 clinical dose has been calculated for the patient group in Study SPD503-107. Based on the