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Author Spotlight: Advancements in CAR-T Cell Manufacturing and Gene Therapy Production
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美国食品和药物管理局对CAR T细胞药理动力学/药理动力学和基于模型的评估的经验

Million A Tegenge1, Xiaofei Wang1, Jiang Liu2

  • 1Office of Clinical Evaluation, Office of Therapeutic Products, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

Clinical pharmacology and therapeutics
|May 4, 2025
PubMed
概括

这篇评论详细介绍了FDAFDA的细节.

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Pharmacokinetic Models: Overview01:20

Pharmacokinetic Models: Overview

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Model Approaches for Pharmacokinetic Data: Physiological Models

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...
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Model Approaches for Pharmacokinetic Data: Distributed Parameter Models

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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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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Analysis Methods of Pharmacokinetic Data: Model and Model-Independent Approaches

Drug disposition in the body is a complex process and can be studied using two major approaches: the model and the model-independent approaches.
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