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Tolerance intervals for assessing individual bioequivalence

E B Brown1, H K Iyer, C M Wang

  • 1Department of Statistics, Colorado State University, Fort Collins 80523, USA.

Statistics in Medicine
|April 15, 1997
PubMed
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Comparing average drug bioavailability may not ensure individual bioequivalence. This study introduces a tolerance interval method to assess individual bioequivalence, considering subject-drug interactions for better formulation interchangeability.

Area of Science:

  • Pharmacokinetics and Drug Development
  • Statistical Modeling in Clinical Trials

Background:

  • Traditional drug equivalence evaluation focuses on average bioavailability.
  • Average bioavailability assessment may not guarantee individual drug formulation interchangeability.
  • Emerging awareness highlights the need for assessing individual bioequivalence.

Purpose of the Study:

  • To introduce a novel statistical procedure for assessing individual bioequivalence.
  • To address the limitations of average bioavailability comparisons.
  • To enable reliable interchangeability assessment of drug formulations on an individual basis.

Main Methods:

  • Development of a tolerance interval procedure.
  • Utilizing a statistical model incorporating subject-by-formulation interaction.

Related Experiment Videos

  • Application to higher-order cross-over designs.

    • Main Results:

    • The proposed tolerance interval procedure provides a method to assess individual bioequivalence.
    • The statistical model accounts for variability between subjects and formulations.
    • Methods are demonstrated with examples for complex cross-over designs.

    Conclusions:

    • Individual bioequivalence assessment is crucial for drug formulation interchangeability.
    • The tolerance interval approach offers a robust statistical framework.
    • This method enhances the evaluation of drug product performance at the individual level.