Australian Public Assessment Report for budesonide
A new 28 day oral repeat dose bridging study in cynomolgous monkeys compared Cortiment tablets and Entocort (budesonide) enteric capsules at doses of 18 mg/day (at least 25 x the MRHD on a mg/kg basis). Systemic budesonide exposure following Cortiment was about half that following Entocort, and exceeded clinical systemic exposure at the MRHD. ................
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