以生理学为基础的药物动力学模型可以预测怀孕期间的药物暴露
Celia Ait-Chikh1, Guylène Page2, Vincent Thoreau2
1Faculté de médecine et pharmacie, université de Poitiers, UFR médecine et pharmacie, bâtiment D1, 6, rue de la Milétrie, TSA 51115, 86073 Poitiers cedex 9, France.
Annales pharmaceutiques francaises
|September 22, 2023
概括
基于生理学的药理动力学 (PBPK) 模型对于了解怀孕期间的药物行为至关重要. 这些模型有助于确定孕妇的安全药物剂量,并评估胎儿的暴露,解决来自有限的临床试验的数据缺口.
科学领域:
- 药理学 药理学是指药理学的学科.
- 药物代谢和药理动力学
- 孕产妇和胎儿医学 孕产妇和胎儿医学
背景情况:
- 怀孕期间的药物安全性至关重要,因为影响药理动力学 (PK) 的生理变化.
- 在孕妇人群中进行的有限的临床试验需要使用替代药物评估方法.
- 了解药物分发,包括胎盘转移,对于胎儿安全至关重要.
研究的目的:
- 审查生理学基础药理动力学 (PBPK) 模型在怀孕中的应用.
- 突出PBPK在孕妇药物剂量确定中的作用.
- 评估胎儿药物暴露和胎儿体内潜在的药物相互作用.
主要方法:
- 基于生理学的药理动力学 (PBPK) 建模方法.
- 药物的物理化学性质和生理参数的整合.
- 在怀孕期间分析药物分布,新陈代谢和分泌.
主要成果:
- PBPK模型有效地描述了怀孕期间药物PK参数的变化.
- 这些模型有助于估计母亲和胎儿的药物度.
- PBPK建模提供了对胎盘药物转移和胎儿暴露的见解.
结论:
- PBPK建模是评估怀孕期间药物安全性的宝贵工具.
- 它支持孕妇对药物剂量进行知情调整.
- PBPK模型增强对胎儿药物暴露和相互作用的理解.
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