Hara T, Koyama K, Miyazaki H, Ohguro Y, Shimizu M
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In previous subacute toxicity studies by intramuscular administration carried out in Beagle dogs for 30 days, its maximum safety dose was not confirmed because renal tubular disorder was observed slightly at the dose of 25 mg/kg. Therefore subacute intramuscular toxicity studies were carried out again to investigate maximum safety dose using lower doses (4, 10 mg/kg). As the result of studies, the maximum safety dose was considered to be 10 mg/kg because there were no abnormal changes at both doses.
在之前对比格犬进行的为期30天的肌肉注射亚急性毒性研究中,由于在25mg/kg剂量下轻微观察到肾小管紊乱,其最大安全剂量未得到确认。因此,再次进行亚急性肌肉毒性研究,使用较低剂量(4、10mg/kg)来研究最大安全剂量。研究结果表明,最大安全剂量被认为是10mg/kg,因为在这两个剂量下均未出现异常变化。