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相关概念视频

Pharmacokinetic Models: Overview01:20

Pharmacokinetic Models: Overview

647
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.
There are three primary types of models: empirical, compartment, and physiological. Empirical models, with minimal...
647
Pharmacokinetic Models: Comparison and Selection Criterion01:26

Pharmacokinetic Models: Comparison and Selection Criterion

66
Physiological and compartmental models are valuable tools used in studying biological systems. These models rely on differential equations to maintain mass balance within the system, ensuring an accurate representation of the dynamic processes at play.
Physiological models take a detailed approach by considering specific molecular processes. They can predict drug distribution, metabolism, and elimination changes, providing a comprehensive understanding of how drugs interact with the body.
66
Model Approaches for Pharmacokinetic Data: Distributed Parameter Models01:06

Model Approaches for Pharmacokinetic Data: Distributed Parameter Models

68
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.
The distributed parameter models are specifically designed to account for variations and differences in some drug classes. This model is particularly useful for assessing regional concentrations of anticancer or...
68
Model Approaches for Pharmacokinetic Data: Physiological Models01:15

Model Approaches for Pharmacokinetic Data: Physiological Models

41
Physiological models in pharmacokinetics are instrumental in understanding the distribution and elimination of drugs within the body. These models describe the drug concentration within target organs, influenced by factors such as drug uptake, tissue volume, and blood flow. Drug uptake is governed by the partition coefficient, which signifies the drug concentration ratio in tissue to that in the blood. The blood flow rate to a specific tissue is expressed as Qt, and the rate of change in tissue...
41
Physiological Pharmacokinetic Models: Assumption with Protein Binding01:13

Physiological Pharmacokinetic Models: Assumption with Protein Binding

39
Physiological models with protein binding in pharmacokinetics offer a sophisticated approach to understanding drug disposition. These models consider drug-protein interactions, enabling them to effectively predict drug concentrations in different organs and tissues. This precision aids in accurate drug dosing, providing a significant advantage over conventional models. A key process within these models is equilibration, which ensures that drug concentrations achieve a steady state within the...
39
Physiological Pharmacokinetic Models: Incorporating Hepatic Transporter-Mediated Clearance01:07

Physiological Pharmacokinetic Models: Incorporating Hepatic Transporter-Mediated Clearance

38
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.
A recent model describes pravastatin's hepatobiliary excretion,...
38

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相关实验视频

Updated: Jun 22, 2025

An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment
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基于生理学的生物制药模型的参数化:研讨会总结报告

Xavier Pepin1, Sumit Arora2, Luiza Borges3

  • 1Regulatory Affairs, Simulations Plus Inc., 42505 10th Street West, Lancaster, California 93534-7059, United States.

Molecular pharmaceutics
|July 1, 2024
PubMed
概括

本次研讨会详细介绍了生理基础生物制药建模 (PBBM) 的最佳实践,以确保药物产品的质量. 专家们讨论了模型参数化,监管期望和预测体内药物性能的方法.

关键词:
在CQAs中,CQAs是:IVIVC IVIVC IVIVC IVIVC IVIVC IVIVC IVIVC IVIVC IVIVC IVIVC IVIVC IVIVC IVIVC IVIVC IVIVC IVIVC IVIVC IVIVC IVIVC IVIVCIVIVR IVIVR 在线视频美国的 PBBM PBBM生物等价性 生物等价性生物预测溶解生物预测溶解建模 建模模型 建模模型透性 透性的降水 降水 降水 降水 降水溶解度 溶解度 溶解度 溶解度

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科学领域:

  • 药理动力学和药物新陈代谢
  • 制药科学 制药科学
  • 计算化学计算化学

背景情况:

  • 基于生理学的生物制药模型 (PBBM) 对于评估药物产品质量至关重要.
  • 监管机构和行业专家召开会议,讨论PBBM最佳实践.
  • 模型参数化仍然是PBBM应用中的一个关键挑战.

研究的目的:

  • 分享关于药物产品质量的 PBBM 最佳实践研讨会的记录.
  • 介绍PBBM案例研究和提交要求的监管观点.
  • 确定和讨论PBBM参数化的最佳实践.

主要方法:

  • 汇编了关于 PBBM 的研讨会的演讲和讨论.
  • 审查监管机构对行业提交的PBMM案例研究的反.
  • 通过突破性会议探索PBBM参数化中的关键科学问题.

主要成果:

  • 监管机构分享了PBBM提交的关键问题和评估过程.
  • 讨论了整合药物溶解性,辅助剂效应和溶解的最佳实践.
  • 研究了模拟 PBBM 药物沉和透性的方法.

结论:

  • 针对PBBM参数化的标准化最佳实践对于监管机构的接受至关重要.
  • 改善了体外数据和机械建模的整合,提高了体内性能预测.
  • 产业和监管机构之间的合作对于推动药物开发中的 PBBM 应用至关重要.