Module 3 2019

Qualification of Impurities

Based on levels dosed in pre-clinical (Tox) studies

● 0,1,3,6 mg/kg/day for 3 months

No treatment related clinical signs

Plasma concentrations proportional to dose

No toxicological effect at any dose studied

● 6 mg/kg/day represents 1000 multiples of human exposure based on: – Acceptance Criterion of 0.8% – Maximum daily dose of 40 mg – Average patient weight of 50 kg Impurity has no structural alerts, therefore only general (not genetic) toxicology needs to be considered to qualify the impurity

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