Module 3 - Strategic case studies in practice

ICH Q3D(R1) Guideline

For continuous dosing = 1.9 mg/m 3 x 6 h/d x 5 d/wk = 0.34 mg/m 3 = 0.00034 mg/L 24 h/d x 7d/wk 1000 L/m 3

Daily dose = 0.00034 mg/L x 1440 L/d = 122.04 µg/kg/day 4 kg

PDE = 122.04 µg/kg/d x 50 kg / 2.5 x 10 x 10 x 1 x 1 = 25 µg/day

R EFERENCES

Grandjean EM, Aubry JM. Lithium: updated human knowledge using an evidence-based approach. Part II: Clinical pharmacology and therapeutic monitoring. CNS Drugs 2009;23(4):331-49. Johansson A, Camner P, Curstedt T, Jarstrand C, Robertson B, Urban T. Rabbit lung after inhalation of lithium chloride. J Appl Toxicol 1988;8:373-5. McKnight RF, Adida M, Budge K, Stockton S, Goodwin GM, Geddes JR. Lithium toxicity profile: a systematic review and meta-analysis. Lancet 2012;379:721-728. US FDA. Lithium carbonate product label, 2011. (available at drugs@fda; accessed May 1, 2014)

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