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On sample size calculation in bioequivalence trials.

Publication ,  Journal Article
Chow, SC; Wang, H
Published in: J Pharmacokinet Pharmacodyn
April 2001

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.

Duke Scholars

Published In

J Pharmacokinet Pharmacodyn

DOI

ISSN

1567-567X

Publication Date

April 2001

Volume

28

Issue

2

Start / End Page

155 / 169

Location

United States

Related Subject Headings

  • Therapeutic Equivalency
  • Sample Size
  • Pharmacology & Pharmacy
  • Humans
  • Cross-Over Studies
  • Clinical Trials as Topic
  • 3214 Pharmacology and pharmaceutical sciences
  • 1115 Pharmacology and Pharmaceutical Sciences
 

Citation

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Chow, S. C., & Wang, H. (2001). On sample size calculation in bioequivalence trials. J Pharmacokinet Pharmacodyn, 28(2), 155–169. https://doi.org/10.1023/a:1011503032353
Chow, S. C., and H. Wang. “On sample size calculation in bioequivalence trials.J Pharmacokinet Pharmacodyn 28, no. 2 (April 2001): 155–69. https://doi.org/10.1023/a:1011503032353.
Chow SC, Wang H. On sample size calculation in bioequivalence trials. J Pharmacokinet Pharmacodyn. 2001 Apr;28(2):155–69.
Chow, S. C., and H. Wang. “On sample size calculation in bioequivalence trials.J Pharmacokinet Pharmacodyn, vol. 28, no. 2, Apr. 2001, pp. 155–69. Pubmed, doi:10.1023/a:1011503032353.
Chow SC, Wang H. On sample size calculation in bioequivalence trials. J Pharmacokinet Pharmacodyn. 2001 Apr;28(2):155–169.
Journal cover image

Published In

J Pharmacokinet Pharmacodyn

DOI

ISSN

1567-567X

Publication Date

April 2001

Volume

28

Issue

2

Start / End Page

155 / 169

Location

United States

Related Subject Headings

  • Therapeutic Equivalency
  • Sample Size
  • Pharmacology & Pharmacy
  • Humans
  • Cross-Over Studies
  • Clinical Trials as Topic
  • 3214 Pharmacology and pharmaceutical sciences
  • 1115 Pharmacology and Pharmaceutical Sciences