合理化适用于儿童的植物治疗药物的最佳剂量:现状 - 潜在的解决方案 - 需要采取的行动
Andreas Hensel1, Rudolf Bauer2, Michael Heinrich3
1Institute of Pharmaceutical Biology and Phytochemistry, University of Münster, Germany.
Planta medica
|March 25, 2024
概括
适用于儿童的草药 (HMP) 是有前途的,但面临监管障碍. 调整监管框架和合理化剂量对于安全有效的儿童使用HMP至关重要.
科学领域:
- 药理学 药理学是指药理学的学科.
- 儿科医学 儿科医学
- 监管科学 监管科学
背景情况:
- 世卫组织强调儿童不是小成年人,这促使欧盟在2007年颁布了儿科法规.
- 尽管有规定,但儿科草药 (HMP) 的进展仍然有限.
- 一场研讨会评估了儿童健康医师的现状和挑战.
研究的目的:
- 评估当前儿科HMP使用情况.
- 找出缺乏进展的原因.
- 讨论在儿童中证明HMP安全性和有效性的策略.
主要方法:
- 审查当前的立法要求和欧洲国家法规.
- 分析现有数据,并考虑新的方法,如真实世界数据 (RWD).
- 关于调整监管框架和合理化剂量策略的讨论.
主要成果:
- 儿科HMP是有效和安全的,但目前的使用不符合立法标准.
- 不同的国家法规和传统使HMP在欧洲的注册和销售变得复杂.
- 欧盟草药专著提供了一个共同的标准,但安全性讨论和RWD是新兴的考虑因素.
结论:
- 显著需要修订对儿科HMP使用的限制.
- 合理化儿童用药方案是必不可少的.
- 调整监管框架并利用RWD可以改善儿科HMP的发展.
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