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Iterated bootstrap procedure in individual bioequivalence

Yıl 2019, Cilt: 68 Sayı: 1, 583 - 594, 01.02.2019
https://doi.org/10.31801/cfsuasmas.438407

Öz

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.

Kaynakça

  • 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.
Yıl 2019, Cilt: 68 Sayı: 1, 583 - 594, 01.02.2019
https://doi.org/10.31801/cfsuasmas.438407

Öz

Kaynakça

  • 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.
Toplam 17 adet kaynakça vardır.

Ayrıntılar

Birincil Dil İngilizce
Bölüm Makaleler
Yazarlar

Ufuk Beyaztas Bu kişi benim 0000-0002-5208-4950

Yayımlanma Tarihi 1 Şubat 2019
Gönderilme Tarihi 27 Mart 2017
Kabul Tarihi 7 Mart 2018
Yayımlandığı Sayı Yıl 2019 Cilt: 68 Sayı: 1

Kaynak Göster

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. Şubat 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, sy. 1 (Şubat 2019): 583-94. https://doi.org/10.31801/cfsuasmas.438407.
EndNote Beyaztas U (01 Şubat 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., c. 68, sy. 1, ss. 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 (Şubat 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, c. 68, sy. 1, 2019, ss. 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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