在临床试验中,使用视觉模拟尺度对口服可分解片的可口性评估
概括
视觉模拟量表 (VAS) 方法可靠地评估口服分解片 (ODT) 的口感,在不同组和评估中显示一致的结果. 这证实了它对制药开发的有效性.
科学领域:
- 制药科学 制药科学
- 感官科学 感官科学
- 临床试验 临床试验
背景情况:
- 视觉模拟尺度 (VAS) 是一种多功能工具,用于评估各种参数.
- 没有先前的研究证实了VAS的顺序效应或可重复性,以获得口服剂型的可口性.
- 评估口感对于患者友好的制药产品设计至关重要.
研究的目的:
- 评估100毫米VAS方法的有效性,以评估口服分解片 (ODT) 的可口性.
- 在ODT可口性评估中研究VAS的可复制性和顺序效应.
主要方法:
- 涉及40名参与者的临床试验评估了三个famotidine ODT (F1,F2,F3).
- 用6个品尝序列的交叉设计来评估跨组的可重复性.
- 组内可重复性由参与者评估相同的ODT两次来评估.
主要成果:
- 总体口感度的VAS评分在所有组中始终显示F3>F2>F1的顺序.
- 在第一和第二次评估之间,VAS得分没有发现显著差异.
- 克鲁斯卡尔-瓦利斯测试表明,评估顺序对ODT评估的影响最小,证实了可靠性和可重复性.
结论:
- 该VAS方法是可靠的和可重复的评估ODT口味.
- 这种经过验证的方法可以为患者友好的制药产品的设计和制造提供信息.
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