On sample size calculation in bioequivalence trials

J Pharmacokinet Pharmacodyn. 2001 Apr;28(2):155-69. doi: 10.1023/a:1011503032353.

Abstract

Sample size calculation plays an important role in bioequivalence trials. In practice, a bioequivalence study is usually conducted under a crossover design or a parallel design with raw data or log-transformed data. In this paper, we discuss the differences in sample size calculation between a crossover design and a parallel design with raw data or log-transformed data. Formulas for sample size calculation under a crossover design and a parallel design with raw data or log-transformed data are derived. A brief discussion for the relationship among these formulas is given.

Publication types

  • Comparative Study

MeSH terms

  • Clinical Trials as Topic / methods*
  • Cross-Over Studies*
  • Humans
  • Sample Size
  • Therapeutic Equivalency