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A spreadsheet program for simulation of bioequivalence and bioavailability studies

H Y Abdallah1, T M Ludden

  • 1Division of Biopharmaceutics, the Food and Drug Administration, Rockville, Maryland, USA.

Computers in Biology and Medicine
|May 1, 1995
PubMed
Summary

This study introduces an Excel spreadsheet tool for simulating bioequivalence (BE) trials. It models variability factors, aiding in the assessment of drug product performance and regulatory compliance.

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Area of Science:

  • Pharmacokinetics and Pharmaceutical Sciences
  • Biostatistics and Clinical Trial Design

Background:

  • Bioequivalence (BE) trials are crucial for demonstrating therapeutic equivalence between drug products.
  • Accurate simulation of BE trials requires accounting for various sources of variability.
  • Existing simulation tools may not be readily accessible or user-friendly.

Purpose of the Study:

  • To present a user-friendly Excel-based spreadsheet program for simulating bioequivalence trials.
  • To incorporate key sources of variability affecting BE study outcomes.
  • To provide a practical tool for researchers and regulatory scientists.

Main Methods:

  • Development of a spreadsheet simulation model in Microsoft Excel for Windows.
  • Inclusion of parameters for intersubject and intrasubject variability in drug absorption and disposition.

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  • Integration of assay precision and dose uniformity into the simulation model.

    • Main Results:

    • The simulation program generates confidence intervals and pass/fail codes for BE studies.
    • The output facilitates the assessment of bioequivalence based on simulated data.
    • An example demonstrates the impact of intrasubject variability on BE trial outcomes for identical formulations.

    Conclusions:

    • The developed Excel spreadsheet offers a practical and accessible method for simulating bioequivalence trials.
    • The tool aids in understanding the influence of variability on BE study results.
    • This simulation approach supports the design and evaluation of bioequivalence studies.