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Robust and bootstrap testing procedures for bioequivalence

C F Shen1, B Iglewicz

  • 1Biometrics Research Department, Merck Research Laboratories, Rahway, New Jersey.

Journal of Biopharmaceutical Statistics
|March 1, 1994
PubMed
Summary
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Bioequivalence studies often face outlier issues. A new 2 beta trimmed-t procedure offers higher power and outlier resistance compared to traditional t-tests, improving bioequivalence conclusions.

Area of Science:

  • Biostatistics
  • Pharmacokinetics
  • Clinical Trials

Background:

  • Outliers are a common challenge in bioequivalence studies.
  • Traditional two one-sided t-tests (Schurirmann's) lack power when outliers are present.
  • This limits the ability to reliably conclude bioequivalence.

Purpose of the Study:

  • To introduce a novel 2 beta trimmed-t procedure for bioequivalence analysis.
  • To demonstrate the advantages of this new procedure over existing methods.
  • To provide statistical justification using bootstrap methods.

Main Methods:

  • Development of the 2 beta trimmed-t procedure.
  • Application of two bootstrap procedures for validation.
  • Monte Carlo simulations under various distributional assumptions for a 2x2 crossover trial.

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Main Results:

  • The 2 beta trimmed-t procedure shows higher efficiency for non-normal symmetric distributions.
  • The procedure is robust and resistant to outliers.
  • Monte Carlo results confirm the procedure's power in 2x2 crossover trials.

Conclusions:

  • The 2 beta trimmed-t procedure offers a more powerful and reliable method for bioequivalence studies, especially with outlier data.
  • Bootstrap methods support the validity of the trimmed-t test.
  • This approach enhances the statistical rigor of bioequivalence assessments.