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Sample size determination for the two one-sided tests procedure in bioequivalence

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Abstract

Approximate formulae of sample sizes for Schuirmann's two one-sided tests procedure are derived for bioequivalence studies with the 2×2 crossover design. These formulae are simple enough to be carried out with a pocket calculator.

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References

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Authors and Affiliations

  1. Biostatistics, Berlex Laboratories, Inc., 300 Fairfield Road, 07470, Wayne, New Jersey

    Jen-pei Liu

  2. Biostatistics and Data Management, Bristol-Myers Squibb Company, 500 College Road East, 08536, Plainsboro, New Jersey

    Shein-Chung Chow

Authors
  1. Jen-pei Liu
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  2. Shein-Chung Chow
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Liu, Jp., Chow, SC. Sample size determination for the two one-sided tests procedure in bioequivalence. Journal of Pharmacokinetics and Biopharmaceutics 20, 101–104 (1992). https://doi.org/10.1007/BF01143188

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  • DOI: https://doi.org/10.1007/BF01143188

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