验证口服药物配方在儿科患者群体中可接受性评估的复合终点:一个随机的,开放的,单剂量,交叉研究
Juliane Münch1, Anna Lena Schwarzwälder1, Carolin Kloft1
1Department of General Pediatrics, Neonatology and Pediatric Cardiology, Medical Faculty and University Hospital Duesseldorf, Heinrich Heine University, Duesseldorf, Germany.
Frontiers in pharmacology
|September 3, 2024
概括
这项研究验证了一种新的复合终点,用于评估儿科药物的可接受性,结合可吞性和可口性. 结果显示了年龄特定的配方偏好,突出显示了终点.
科学领域:
- 药理学和制药科学 药理学和制药科学
- 儿科药物开发 儿科药物开发
- 临床试验方法论 临床试验方法论
背景情况:
- 评估口服儿科药物配方的可接受性对于治疗成功和治疗成功至关重要.
- 现有的方法可能无法完全捕捉影响儿童接受药物的复杂因素.
- 可吞性和可口性是儿童群体药物可接受性的关键决定因素.
研究的目的:
- 为验证口服儿科药物配方新开发的复合性可接受性终点.
- 将可吞性和可口性评估整合到药物可接受性的统一衡量标准中.
- 评估这个复合终点在不同儿科年龄组和配方的敏感性.
主要方法:
- 进行了一项开放的标签研究,涉及320名儿童,分为三个年龄组:1-6个月,6-12岁和12-18岁.
- 最年轻的组 (糖和迷你片) 使用了双向交叉设计.
- 一个不完整的块设计与四个序列评估糖,迷你片,长方形片和圆形片在老年儿童 (6-<18岁).
主要成果:
- 复合物可接受性终点表明,配方接受度因年龄而异.
- 迷你片对1-6个月和6-12岁的儿童是最可接受的.
- 青少年 (12-<18岁) 倾向于使用长方形药片.
结论:
- 综合性可接受性终点,整合可吞性和可口性,是评估儿科药物可接受性的敏感工具.
- 这种验证的终点可以有效地根据特定年龄的偏好区分配方.
- 这些发现支持在儿科药物开发和配方设计中使用这种综合终点.
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