The popularity of botanical and other purported medicinal natural products (NPs) continues to grow, especially among patients with chronic illnesses and patients managed on complex prescription drug regimens. With few exceptions, the risk of a given NP to precipitate a clinically significant pharmacokinetic NP-drug interaction (NPDI) remains understudied or unknown. Application of static or dynamic mathematical models to predict and/or simulate NPDIs can provide critical information about the potential clinical significance of these complex interactions. However, methods used to conduct such predictions or simulations are highly variable. Additionally, published reports using mathematical models to interrogate NPDIs are not always sufficiently detailed to ensure reproducibility. Consequently, guidelines are needed to inform the conduct and reporting of these modeling efforts. This recommended approach from the Center of Excellence for Natural Product Drug Interaction Research describes a systematic method for using mathematical models to interpret the interaction risk of NPs as precipitants of potential clinically significant pharmacokinetic NPDIs. A framework for developing and applying pharmacokinetic NPDI models is presented with the aim of promoting accuracy, reproducibility, and generalizability in the literature.

中文翻译：

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模拟药代动力学天然产物-药物相互作用以进行决策：NaPDI 中心推荐的方法

植物和其他所谓的药用天然产品 (NP) 的受欢迎程度持续增长，尤其是在慢性病患者和接受复杂处方药治疗的患者中。除少数例外，特定 NP 引发具有临床意义的药代动力学 NP-药物相互作用 (NPDI) 的风险仍未得到充分研究或未知。应用静态或动态数学模型来预测和/或模拟 NPDI 可以提供有关这些复杂相互作用的潜在临床意义的关键信息。然而，用于进行此类预测或模拟的方法变化很大。此外，使用数学模型来询问 NPDI 的已发表报告并不总是足够详细以确保可重复性。因此，需要指导方针来指导这些建模工作的实施和报告。天然产物药物相互作用研究卓越中心推荐的方法描述了一种系统方法，使用数学模型来解释 NP 作为潜在具有临床意义的药代动力学 NPDI 沉淀剂的相互作用风险。提出了开发和应用药代动力学 NPDI 模型的框架，旨在提高文献中的准确性、可重复性和普遍性。