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TopFit: a PC-based pharmacokinetic/pharmacodynamic data analysis program

P Tanswell1, J Koup

  • 1Department of Pharmacokinetics and Metabolism, Dr. Karl Thomae GmbH, Biberach, Germany.

International Journal of Clinical Pharmacology, Therapy, and Toxicology
|October 1, 1993
PubMed
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TopFit is a validated software program designed for pharmacokinetic data analysis and kinetic/dynamic evaluation in drug development. It supports regulatory submissions and offers flexible modeling capabilities without requiring user programming.

Area of Science:

  • Pharmacokinetics
  • Pharmaceutical Development
  • Computational Biology

Background:

  • Drug development requires robust pharmacokinetic (PK) data analysis for regulatory submissions.
  • Model-based kinetic/dynamic (K/D) evaluation is crucial for understanding drug behavior during development.
  • Existing tools may lack flexibility or require programming expertise.

Purpose of the Study:

  • To introduce TopFit, a software program developed for pharmacokinetic data analysis.
  • To highlight TopFit's utility in supporting international regulatory submissions.
  • To showcase TopFit's advanced capabilities for model-based K/D evaluation in drug development.

Main Methods:

  • TopFit incorporates non-compartmental analysis methods.
  • It utilizes standard compartment models built from input and disposition modules.

Related Experiment Videos

  • The software offers a library of 24 non-linear models and supports unlimited linear user-defined models.

    • Main Results:

    • TopFit provides comprehensive pharmacokinetic data analysis support.
    • It facilitates model-based kinetic/dynamic evaluation during drug development.
    • The program ensures data exchange compatibility with other software like SAS.

    Conclusions:

    • TopFit is a validated, user-friendly software solution for pharmaceutical pharmacokinetic analysis.
    • It streamlines drug development processes and regulatory submissions.
    • Version 2.0 is commercially available for PC users.