Module 3 - Strategic case studies in practice

ICH Q3D(R1) Guideline

lowest dose tested, 0.5 mg/m 3 vanadium pentoxide (Ress et al. 2003). Vanadium pentoxide is a caustic agent and is not considered to be present in drug products. Therefore, the inhalation PDE for vanadium was calculated by dividing the oral PDE by a modifying factor of 100 (as described in Section 3.1).

PDE = 120 µg/d / 100 = 1.2 µg/day

R EFERENCES

ATSDR. Toxicological profile for vanadium. Agency for Toxic Substances and Disease Registry, Public Health Service, U.S. Department of Health and Human Services, Atlanta, GA. 2012. IARC. Arsenic, metals, fibres, and dusts: a review of human carcinogens. Monographs on the Evaluation of Carcinogenic Risks to Humans. International Agency for Research on Cancer, World Health Organization, Lyon. 2012;100C. Ress NB, Chou BJ, Renne RA, Dill JA, Miller RA, Roycroft JH et al. Carcinogenicity of inhaled vanadium pentoxide in F344/N rats and B6C3F1 mice. Toxicol Sci 2003;74(2):287-96.

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