用于暴露预测的PBPK模型介绍

IF 2.9 3区医学 Q2 TOXICOLOGY

Toxicology letters Pub Date : 2025-09-01 DOI:10.1016/j.toxlet.2025.07.020

A. Olivares-Morales

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引用次数: 0

摘要

本讲座将介绍基于生理的药代动力学（PBPK）建模作为预测新型小分子疗法在人类和非临床安全物种（如动物）中的药代动力学的工具的使用。该模型有助于预测预期的治疗暴露/剂量和相应的安全边际，以便在首次人体试验之前做出决策。讲座将涵盖PBPK概念的入门部分，其在安全性预测中的用途，并提供逐步估计安全边际的例子，这是制药行业的常见做法。

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CEC03-01 Introduction to PBPK modeling for exposure predictions

This lecture will provide an introduction to the use of physiologically-based pharmacokinetic (PBPK) modeling as a tool to predict the pharmacokinetics of novel small molecule therapeutics in both humans and non-clinical safety species, such as animals. This modeling helps predict the anticipated therapeutic exposure/doses and the corresponding safety margins to enable decision-making before first-in-human trials. The lecture will cover an introductory component to the concept of PBPK, its usefulness in safety prediction, and provide examples of a step-by-step estimation of safety margins, which is common practice in the pharmaceutical industry.

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