Australian Public Assessment Report for Alectinib ...

Dosing in the pivotal 13 week rat study was limited by toxicity including short and crushed teeth and reductions in body weights (16 to 22%) at the high dose (27 mg/kg/day). The maximum dose in the 13 week study in monkeys (12 mg/kg/day) resulted in no overt signs or effects on body weight gain. Higher doses could have been administered. ................
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