On sample size calculation in bioequivalence trials.

Published

Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Chow, SC; Wang, H

Published Date

  • April 2001

Published In

Volume / Issue

  • 28 / 2

Start / End Page

  • 155 - 169

PubMed ID

  • 11381568

Pubmed Central ID

  • 11381568

International Standard Serial Number (ISSN)

  • 1567-567X

Language

  • eng

Conference Location

  • United States