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A note on sample size determination for bioequivalence studies with high-order crossover designs.

Publication ,  Journal Article
Chen, KW; Chow, SC; Li, G
Published in: J Pharmacokinet Biopharm
December 1997

Similar to Liu and Chow, approximate formulas for sample size determination are derived based on Schuirmann's two one-sided tests procedure for bioequivalence studies for the additive and the multiplicative models under various higher order crossover designs for comparing two formulations of a drug product. The higher order crossover designs under study include Balaam's design, the two-sequence dual design, and two four-period designs (with two and four sequences), which are commonly used for assessment of bioequivalence between formulations. The derived formulas are simple enough to be carried out with a pocket calculator. The number of subjects required for each of the four higher order designs are tabulated for selected powers and various parameter values.

Duke Scholars

Published In

J Pharmacokinet Biopharm

DOI

ISSN

0090-466X

Publication Date

December 1997

Volume

25

Issue

6

Start / End Page

753 / 765

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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Chen, K. W., Chow, S. C., & Li, G. (1997). A note on sample size determination for bioequivalence studies with high-order crossover designs. J Pharmacokinet Biopharm, 25(6), 753–765. https://doi.org/10.1023/a:1025738019069
Chen, K. W., S. C. Chow, and G. Li. “A note on sample size determination for bioequivalence studies with high-order crossover designs.J Pharmacokinet Biopharm 25, no. 6 (December 1997): 753–65. https://doi.org/10.1023/a:1025738019069.
Chen KW, Chow SC, Li G. A note on sample size determination for bioequivalence studies with high-order crossover designs. J Pharmacokinet Biopharm. 1997 Dec;25(6):753–65.
Chen, K. W., et al. “A note on sample size determination for bioequivalence studies with high-order crossover designs.J Pharmacokinet Biopharm, vol. 25, no. 6, Dec. 1997, pp. 753–65. Pubmed, doi:10.1023/a:1025738019069.
Chen KW, Chow SC, Li G. A note on sample size determination for bioequivalence studies with high-order crossover designs. J Pharmacokinet Biopharm. 1997 Dec;25(6):753–765.

Published In

J Pharmacokinet Biopharm

DOI

ISSN

0090-466X

Publication Date

December 1997

Volume

25

Issue

6

Start / End Page

753 / 765

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