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应用SVG-101的种群药动力学建模来评估适当的剂量选择
Kyoung Hoon Mo1,2, Dongwoo Chae1,3, Yun Seob Jung4
1Department of Clinical Pharmacology, Severance Hospital, Yonsei University Health System, Seoul 03722, Korea.
一个新的可分散的Everolimus片 (SVG101) 在健康成年人中显示出有前途的药理动力学. 建议每天服用3-4毫克的剂量,以维持治疗度的最低水平,对于患有吞困难的患者.
科学领域:
- 药理学 药理学是指药理学的学科.
- 药物开发 药物开发
背景情况:
- 埃弗罗利斯治疗结核性硬化综合体 (TSC),癌症,并有助于器官移植.
- 对于儿科TSC患者,有一个可分散的配方,但对于难以吞的成年人没有.
研究的目的:
- 为了评估一种新的可分散恒立片 (SVG101) 的药理动力学.
- 为了确定一个最佳的剂量方案,对于成年人的吞困难.
主要方法:
- 一项随机的,开放的,2x2交叉研究,对26名健康的韩国男性进行.
- 使用具有双吸收动态的两部分模型进行种群药理动力学建模.
主要成果:
- 药物动力学模型显示,观察和预测度之间存在良好的一致性.
- 模拟表明,每日剂量为3-4毫克的可分散的常利可以维持治疗度的最低值 (5-15 ng/mL).
结论:
- 建议成年人每天服用3-4毫克的分散性常利,以使他们难以吞.
- 这种配方可以改善成年人的吞挑战的坚持和结果.
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