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The top-down Physiologically Based Finite Time Pharmacokinetic (PBFTPK) models open a new avenue for early drug development.

European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences·2026
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The Finite Absorption Time Concept Guiding Model Informed Drug & Generics Development in Clinical Pharmacology.

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IVIVC Revised.

Nikolaos Alimpertis1,2, Antony Simitopoulos1, Athanasios A Tsekouras2,3

  • 1Faculty of Pharmacy, National and Kapodistrian University of Athens, Athens, Greece.

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|January 8, 2024
PubMed
Summary

This study revises in vitro-in vivo correlations (IVIVC) using Finite Absorption Time (F.A.T.) and Finite Dissolution Time (F.D.T.) concepts. New methods reveal drug absorption kinetics, improving physiological insight into dissolution processes.

Keywords:
IVIVCcarbamazepinecyclosporinefinite absorption timefinite dissolution timelevy plotoral drug absorption

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Area of Science:

  • Pharmacokinetics
  • Drug Dissolution and Absorption

Background:

  • In vitro-in vivo correlations (IVIVC) are crucial for predicting drug performance.
  • Existing IVIVC models may not fully capture the physiological complexities of drug absorption and dissolution.
  • Finite Absorption Time (F.A.T.) and Finite Dissolution Time (F.D.T.) offer a more physiologically sound framework.

Purpose of the Study:

  • To revise existing IVIVC methodologies.
  • Incorporate the physiologically relevant concepts of F.A.T. and F.D.T. into IVIVC.
  • Enhance the understanding of drug dissolution and absorption processes.

Main Methods:

  • Developed a modified Levy plot incorporating estimates for F.A.T. (τ) and F.D.T. (τd).
  • Applied physiologically based pharmacokinetic (PBFTPK) models to analyze drug absorption kinetics.
  • Reanalyzed bioequivalence study data for carbamazepine and evaluated theophylline dissolution.

Main Results:

  • The modified Levy plot highlighted discrepancies between in vitro dissolution (≈2 h) and in vivo absorption (≈17 h) durations.
  • PBFTPK models confirmed complex, multi-stage absorption processes for carbamazepine.
  • Nonlinear relationships were observed in modified Levy and IVIVC plots for carbamazepine.

Conclusions:

  • Integrating F.A.T. and F.D.T. concepts into Levy plots and IVIVC provides deeper physiological insights.
  • This revised approach improves the understanding of in vitro and in vivo drug dissolution and absorption.
  • The findings support more accurate prediction of drug behavior based on dissolution data.