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Modelling and PBPK simulation in drug discovery.

Hannah M Jones1, Iain B Gardner, Kenny J Watson

  • 1Pfizer Global R&D, Department of Pharmacokinetics, Dynamics and Metabolism, IPC 654, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK. hannah.jones@pfizer.com

The AAPS Journal
|March 13, 2009
PubMed
Summary
This summary is machine-generated.

Physiologically based pharmacokinetic (PBPK) models integrate preclinical data for drug discovery. These mechanistic models predict human pharmacokinetics, reducing animal testing and guiding compound selection.

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Area of Science:

  • Pharmacokinetics and Drug Metabolism
  • Computational Biology
  • Drug Discovery and Development

Background:

  • Physiologically based pharmacokinetic (PBPK) models utilize differential equations and are available in commercial software.
  • These models require species- and compound-specific parameters to predict drug concentrations in plasma and tissues.
  • PBPK models integrate diverse preclinical data into a mechanistic framework.

Purpose of the Study:

  • To review the applications and limitations of PBPK techniques in drug discovery.
  • To highlight the utility of PBPK models in prioritizing compounds for animal pharmacokinetic studies during lead development.
  • To discuss the role of PBPK in predicting human pharmacokinetics for clinical candidate selection and first-in-human studies.

Main Methods:

  • Review of existing literature and case studies on PBPK model applications in drug discovery.
  • Analysis of PBPK model capabilities for predicting compound behavior across species.
  • Discussion of PBPK model parameterization and validation strategies.

Main Results:

  • PBPK models offer mechanistic insights into compound properties and guide experimental design.
  • These models enable prediction of human plasma concentration-time profiles with reduced reliance on animal data.
  • PBPK models are valuable for compound prioritization and early-stage clinical development planning.

Conclusions:

  • PBPK modeling is a powerful tool for enhancing efficiency and reducing attrition in drug discovery.
  • The application of PBPK models facilitates informed decision-making from lead development to first-in-human studies.
  • PBPK approaches minimize animal usage while maximizing the predictive power for human pharmacokinetics.