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Pharmacokinetic Models: Comparison and Selection Criterion01:26

Pharmacokinetic Models: Comparison and Selection Criterion

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.
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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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Use of Rabbit Eyes in Pharmacokinetic Studies of Intraocular Drugs
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Best Practices in Physiologically Based Pharmacokinetic (PBPK) Modeling.

Marylore Chenel1, Andre Dallmann2, Ibrahim Ince3

  • 1Pharmetheus AB, Uppsala, Sweden.

CPT: Pharmacometrics & Systems Pharmacology
|July 4, 2026
PubMed
Summary

Physiologically based pharmacokinetic (PBPK) modeling is crucial for drug development. This paper offers best-practice guidance to improve PBPK model quality and regulatory acceptance, ensuring reliable model-informed drug development (MIDD).

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Published on: December 3, 2020

Area of Science:

  • Pharmacokinetics and Drug Metabolism
  • Regulatory Science
  • Computational Biology

Background:

  • Physiologically based pharmacokinetic (PBPK) modeling is a key component of model-informed drug development (MIDD), supporting regulatory decisions.
  • PBPK models are used for drug-drug interactions, special populations, and clinical study waivers.
  • A gap exists between submitted PBPK analyses quality and regulatory expectations, with many models not deemed qualified.

Purpose of the Study:

  • To provide comprehensive best-practice guidance for PBPK model development, verification, validation, and applicability assessment.
  • To address the need for consolidated guidance and harmonize terminology with ICH M15.
  • To enhance the quality, consistency, and regulatory acceptance of PBPK analyses.

Main Methods:

  • Delineating strategies for defining explicit technical criteria for PBPK model qualification.
  • Proposing methods for verification, validation, and applicability assessment.
  • Consolidating best practices for PBPK model development and application.

Main Results:

  • The guidance aims to ensure PBPK models are appropriately qualified and fit-for-purpose.
  • Implementation of these best practices is expected to improve the reliability of MIDD evidence.
  • Harmonized terminology and expectations will facilitate regulatory review.

Conclusions:

  • Enhanced PBPK modeling guidance is essential for robust model-informed drug development.
  • Adherence to best practices will strengthen regulatory acceptance of PBPK analyses.
  • This work supports the reliable application of PBPK modeling in drug development and approval.