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Related Experiment Videos

On statistical power for average bioequivalence testing under replicated crossover designs.

Hansheng Wan1, Shein-Chung Chow

  • 1StatPlus, Inc., Heston Hall, Yardley, PA 19067, USA. hwang@statplusinc.com

Journal of Biopharmaceutical Statistics
|November 27, 2002
PubMed
Summary

The U.S. Food and Drug Administration (FDA) recommends replicated crossover designs for bioequivalence studies. This study provides a power function and sample size formula for assessing average bioequivalence (ABE) using these designs.

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Area of Science:

  • Pharmacokinetics and Drug Development
  • Statistical Methods in Clinical Trials
  • Regulatory Science

Background:

  • The U.S. Food and Drug Administration (FDA) guidance recommends replicated crossover designs for bioequivalence assessment.
  • Replicated crossover designs allow estimation of various variability components and assessment of average bioequivalence (ABE).

Purpose of the Study:

  • To study the power function for assessing ABE under a general replicated crossover design (2 x 2m).
  • To provide a formula for sample size calculation based on the derived power function.

Main Methods:

  • The study analyzes the power function for ABE assessment using traditional analysis of variance and FDA-recommended mixed effects models.
  • A general replicated crossover design (2 x 2m) is considered.

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Main Results:

  • The power of a 2 x 2m replicated crossover design is influenced by subject-by-formulation interaction variability and the number of replicates.
  • A formula for sample size calculation for ABE assessment under this design is derived.

Conclusions:

  • The findings support the use of replicated crossover designs for bioequivalence studies.
  • The derived power function and sample size formula can aid in the efficient design of bioequivalence trials.