授权为儿科的口服配方的适合年龄
Hannah R Weiler1, Lauren M Le1, Hala M Fadda2
1Department of Pharmaceutical Sciences, College of Pharmacy and Health Sciences, Butler University, Indianapolis, IN, 46208, USA.
Pharmaceutical research
|March 17, 2026
概括
许多儿科口服药物不适合年龄,特别是对于新生儿. 配方缺口仍然存在,突出需要更好的儿科药物开发和监管支持.
科学领域:
- 制药科学 制药科学
- 儿科医学 儿科医学
- 监管科学 监管科学
背景情况:
- 全球监管倡议旨在改善儿科基于证据的医学.
- 现有的法规包括儿科规则,儿童最佳药品法案和儿科研究公平法案.
研究的目的:
- 评估口服儿科配方的适合年龄.
- 评估根据美国FDA的关键儿科法规授权的药物.
主要方法:
- 使用了世界卫生组织适应的儿科质量产品概况工具.
- 评估配方适合年龄的剂量,可接受性,辅助剂的安全性和管理.
- 在儿童子组的1-3级风险尺度上得分属性.
主要成果:
- 不到三分之一的新生儿配方符合适龄标准.
- 药片和囊 (58%) 通常不适合幼儿使用.
- 对于新生儿的液体配方和老年儿童的吞性问题是令人担忧的.
结论:
- 儿科医学中存在持续的配方差距,特别是辅助剂的可接受性和安全性.
- 非传统的固体剂量形式未得到充分利用.
- 监管框架需要加强,以促进儿科药物开发.
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