Research Article

Iterated bootstrap procedure in individual bioequivalence

Volume: 68 Number: 1 February 1, 2019
  • Ufuk Beyaztas
EN

Iterated bootstrap procedure in individual bioequivalence

Abstract

In this paper, we propose an iterating principle in the bootstrap method to assess the individual bioequivalence under 2×4 randomized crossover design. The finite sample properties of the proposed algorithm are illustrated by an extensive simulation study and a real-world example. Our findings reveal that the proposed idea have better performance than the classical percentile bootstrap confidence limits.

Keywords

References

  1. Beran, R., Prepivoting to reduce level error of confidence sets, Biometrika (1987), 74, 151-173.
  2. DiCiccio, T. J. and Romano, J. P., A Review of Bootstrap Confidence Intervals, Journal of The Royal Statistical Society Series B-statistical Methodology (1998), 50, 338-354.
  3. FDA, In vivo bioequivalence studies based on population and individual bioequivalence approaches, Guidance for Industry, Rockville, MD: Center for Drug Evaluation and Research, Food and Drug Administration, 1997.
  4. FDA, Guidance for industry: Bioavaibility and bioequivalence studies for orally administered drug products: General Consideration, Rockville, MD: Center for Drug Evaluation and Research, Food and Drug Administration, 2003.
  5. Hall, P. On the bootstrap and confidence intervals, Annals of Statistics (1986), 54, 1431-1452.
  6. Hall, P. and Martin, M. A., On bootstrap resampling and iteration, Biometrika (1988), 75, 661-671.
  7. Hauschke, D., Steinijans, V., Pigeot, I., Bioequivalence studies in drug development, John Willey & Sons, 2007.
  8. Jones, B. and Kenward, M. G., Design and analysis of cross-over trials, Chapman & Hall/CRC, 2003.

Details

Primary Language

English

Subjects

-

Journal Section

Research Article

Publication Date

February 1, 2019

Submission Date

March 27, 2017

Acceptance Date

March 7, 2018

Published in Issue

Year 2019 Volume: 68 Number: 1

APA
Beyaztas, U. (2019). Iterated bootstrap procedure in individual bioequivalence. Communications Faculty of Sciences University of Ankara Series A1 Mathematics and Statistics, 68(1), 583-594. https://doi.org/10.31801/cfsuasmas.438407
AMA
1.Beyaztas U. Iterated bootstrap procedure in individual bioequivalence. Commun. Fac. Sci. Univ. Ank. Ser. A1 Math. Stat. 2019;68(1):583-594. doi:10.31801/cfsuasmas.438407
Chicago
Beyaztas, Ufuk. 2019. “Iterated Bootstrap Procedure in Individual Bioequivalence”. Communications Faculty of Sciences University of Ankara Series A1 Mathematics and Statistics 68 (1): 583-94. https://doi.org/10.31801/cfsuasmas.438407.
EndNote
Beyaztas U (February 1, 2019) Iterated bootstrap procedure in individual bioequivalence. Communications Faculty of Sciences University of Ankara Series A1 Mathematics and Statistics 68 1 583–594.
IEEE
[1]U. Beyaztas, “Iterated bootstrap procedure in individual bioequivalence”, Commun. Fac. Sci. Univ. Ank. Ser. A1 Math. Stat., vol. 68, no. 1, pp. 583–594, Feb. 2019, doi: 10.31801/cfsuasmas.438407.
ISNAD
Beyaztas, Ufuk. “Iterated Bootstrap Procedure in Individual Bioequivalence”. Communications Faculty of Sciences University of Ankara Series A1 Mathematics and Statistics 68/1 (February 1, 2019): 583-594. https://doi.org/10.31801/cfsuasmas.438407.
JAMA
1.Beyaztas U. Iterated bootstrap procedure in individual bioequivalence. Commun. Fac. Sci. Univ. Ank. Ser. A1 Math. Stat. 2019;68:583–594.
MLA
Beyaztas, Ufuk. “Iterated Bootstrap Procedure in Individual Bioequivalence”. Communications Faculty of Sciences University of Ankara Series A1 Mathematics and Statistics, vol. 68, no. 1, Feb. 2019, pp. 583-94, doi:10.31801/cfsuasmas.438407.
Vancouver
1.Ufuk Beyaztas. Iterated bootstrap procedure in individual bioequivalence. Commun. Fac. Sci. Univ. Ank. Ser. A1 Math. Stat. 2019 Feb. 1;68(1):583-94. doi:10.31801/cfsuasmas.438407

Communications Faculty of Sciences University of Ankara Series A1 Mathematics and Statistics

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