药物基因组学和儿科药物开发:科学和政治权力. 一个叙事审查
Earl B Ettienne1, Jane M Grant-Kels2, Pasquale Striano3
1College of Pharmacy, Howard University, Washington, DC, USA.
Expert opinion on pharmacotherapy
|September 13, 2024
概括
药物基因组学和发育药理学提供了关于老化过程中药物代谢变化的见解. 需要客观的成熟度措施来完善儿科药物开发,避免冗余的研究.
科学领域:
- 药物基因组学 (PGx) 是一个学科.
- 发展性药理学 (DP)
背景情况:
- PGx研究了对酶表达的基因组控制.
- DP概述了影响药物吸收,分布,新陈代谢和分泌 (ADME) 的酶变化.
研究的目的:
- 重新评估对未成年人ADME变化的过时解释.
- 倡导儿童药物开发 (PDD) 的客观成熟度措施.
- 解决法规规定的可能冗余的儿科研究的伦理问题.
主要方法:
- 审查关于PGx和DP的现有文献.
- 对美国和欧盟PDD的立法框架的分析.
- 基于赫尔辛基宣言的伦理考虑.
主要成果:
- PGx提供了对药物安全性和疗效在整个生命周期的变化更深入的了解.
- 当前的PDD实践往往混了"童年"的法律和生理定义.
- 酶模式和药物代谢随着青春期和衰老显著变化.
结论:
- 重新考虑未成年人的ADME变化至关重要.
- 有必要区分"儿童"的法律和生理定义,并使用客观的成熟度指标.
- 避免不必要的儿科研究符合伦理研究原则.
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