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Pravastatin sodium was successively given for 104 weeks to beagles orally at doses of 5 and 25 mg/kg/day. A decrease in serum cholesterol levels was observed at week 4 and thereafter. No other abnormal findings were obtained in any animals in general conditions, hematological and biochemical examination, various function tests, and pathological examinations. The no-effect dose level in beagles receiving pravastatin sodium orally for 104 weeks is toxicologically estimated to be more than 25 mg/kg/day.

LONG TERM ORAL ADMINISTRATION STUDY OF PRAVASTATIN SODIUM TO BEAGLES FOR 104 WEEKS