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目前在EMA的新药批准中使用基于生理学的药理动力学建模

Polly Paul1, Pieter J Colin1,2, Flora Musuamba Tshinanu3,4

  • 1European Medicines Agency, Amsterdam, The Netherlands.

Clinical pharmacology and therapeutics
|January 3, 2025
PubMed
概括

欧洲药品管理局 (EMA) 营销申请中的大多数生理基础药理动力学 (PBPK) 模型都不符合其预期用途. 本次审查强调了共同的问题,以及需要更明确的EMA关于PBPK模型资格的指导.

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Pharmacokinetic models utilize mathematical analysis to achieve a detailed quantitative understanding of a drug's life cycle within the body. They are instrumental in simulating a drug's pharmacokinetic parameters, predicting drug concentrations over time, optimizing dosage regimens, linking concentrations with pharmacologic activity, and estimating potential toxicity.
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Physiological Pharmacokinetic Models: Incorporating Hepatic Transporter-Mediated Clearance

Drug transporters are critical in drug absorption, distribution, and excretion processes. They should be included in physiological-based pharmacokinetic (PBPK) models, which help predict human drug disposition. However, predicting this is challenging during drug development, especially when liver transport is involved. However, with a realistic representation of body transport processes, an accurate model may be possible.
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Pharmacokinetic models are mathematical constructs that represent and predict the time course of drug concentrations in the body, providing meaningful pharmacokinetic parameters. These models are categorized into compartment, physiological, and distributed parameter models.
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