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Iterated bootstrap procedure in individual bioequivalence

Year 2019, , 583 - 594, 01.02.2019
https://doi.org/10.31801/cfsuasmas.438407

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.

References

  • Beran, R., Prepivoting to reduce level error of confidence sets, Biometrika (1987), 74, 151-173.
  • 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.
  • 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.
  • 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.
  • Hall, P. On the bootstrap and confidence intervals, Annals of Statistics (1986), 54, 1431-1452.
  • Hall, P. and Martin, M. A., On bootstrap resampling and iteration, Biometrika (1988), 75, 661-671.
  • Hauschke, D., Steinijans, V., Pigeot, I., Bioequivalence studies in drug development, John Willey & Sons, 2007.
  • Jones, B. and Kenward, M. G., Design and analysis of cross-over trials, Chapman & Hall/CRC, 2003.
  • Martin, M. A., On bootstrap iteration for coverage correction in confidence intervals, Journal of the American Statistical Association (1990), 85, 1105--1118.
  • Pigeot, I., The bootstrap percentile in Food and Drug Administration Regulations for bioequivalence assessment, Drug Information Journal (2001), 35, 1445-1453.
  • Pigeot, I., Hauschke, D. and Shao, J., The bootstrap in bioequivalence studies, Journal of Biopharmaceutical Statistics (2011), 21, 1126-1139.
  • Schall, R. and Luus, H. G., On population and individual bioequivalence, Statistics in Medicine (1993), 12, 1109-1124.
  • Schall, R., Assessment of individual and population bioequivalence using the probability that bioavailabilities are similar, Biometrics (1995), 54, 615-626.
  • Schall, R. and Williams, R. L., Towards a practical strategy for assessing individual bioequivalence, Journal of Pharmacokinetics and Biopharmaceutics (1996), 24, 133-149.
  • Senn, S. J., Cross-over trials in clinical research, John Willey, 1993.
  • Shao, J., Chow, S. C. and Wang, B., The bootstrap procedure in individual bioequivalence, Statistics in Medicine (2000), 19, 2741-2754.
  • Shao, J., Kubler, J. and Pigeot, I., Consistency of the Bootstrap Procedure in Individual Bioequivalence, Biometrika (2000), 87, 573-585.
Year 2019, , 583 - 594, 01.02.2019
https://doi.org/10.31801/cfsuasmas.438407

Abstract

References

  • Beran, R., Prepivoting to reduce level error of confidence sets, Biometrika (1987), 74, 151-173.
  • 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.
  • 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.
  • 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.
  • Hall, P. On the bootstrap and confidence intervals, Annals of Statistics (1986), 54, 1431-1452.
  • Hall, P. and Martin, M. A., On bootstrap resampling and iteration, Biometrika (1988), 75, 661-671.
  • Hauschke, D., Steinijans, V., Pigeot, I., Bioequivalence studies in drug development, John Willey & Sons, 2007.
  • Jones, B. and Kenward, M. G., Design and analysis of cross-over trials, Chapman & Hall/CRC, 2003.
  • Martin, M. A., On bootstrap iteration for coverage correction in confidence intervals, Journal of the American Statistical Association (1990), 85, 1105--1118.
  • Pigeot, I., The bootstrap percentile in Food and Drug Administration Regulations for bioequivalence assessment, Drug Information Journal (2001), 35, 1445-1453.
  • Pigeot, I., Hauschke, D. and Shao, J., The bootstrap in bioequivalence studies, Journal of Biopharmaceutical Statistics (2011), 21, 1126-1139.
  • Schall, R. and Luus, H. G., On population and individual bioequivalence, Statistics in Medicine (1993), 12, 1109-1124.
  • Schall, R., Assessment of individual and population bioequivalence using the probability that bioavailabilities are similar, Biometrics (1995), 54, 615-626.
  • Schall, R. and Williams, R. L., Towards a practical strategy for assessing individual bioequivalence, Journal of Pharmacokinetics and Biopharmaceutics (1996), 24, 133-149.
  • Senn, S. J., Cross-over trials in clinical research, John Willey, 1993.
  • Shao, J., Chow, S. C. and Wang, B., The bootstrap procedure in individual bioequivalence, Statistics in Medicine (2000), 19, 2741-2754.
  • Shao, J., Kubler, J. and Pigeot, I., Consistency of the Bootstrap Procedure in Individual Bioequivalence, Biometrika (2000), 87, 573-585.
There are 17 citations in total.

Details

Primary Language English
Journal Section Review Articles
Authors

Ufuk Beyaztas This is me 0000-0002-5208-4950

Publication Date February 1, 2019
Submission Date March 27, 2017
Acceptance Date March 7, 2018
Published in Issue Year 2019

Cite

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

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

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