Bootstrap and MLS Methods-based Individual Bioequivalence Assessment

Authors: Kongsheng Zhang, Li Ge

Abstract:

It is a one-sided hypothesis testing process for assessing bioequivalence. Bootstrap and modified large-sample(MLS) methods are considered to study individual bioequivalence(IBE), type I error and power of hypothesis tests are simulated and compared with FDA(2001). The results show that modified large-sample method is equivalent to the method of FDA(2001) .

Keywords: Individual bioequivalence, bootstrap, Bayesian bootstrap, modified large-sample.

Digital Object Identifier (DOI): doi.org/10.5281/zenodo.1328594

References:

[1] H. P. Wijnand, Assessment of average, population and individual bioequivalence in two- and four- period crossover studies. Computer Methods and Programs in Bioequivalence, 70(2003)21-35.
[2] US Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Guidance for Industry In vivo bioequivalence studies based on population and individual bioequivalence approaches. Rockville, MD. 1997.
[3] US Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Guidance for Industry Statistical Approaches to Establishing bioequivalence. Rockville, MD. 2001.
[4] J. Shao, S. C. Chow, B. Wang, The bootstrap procedure in individual bioequivalence. Statistics in Medicine, 19(2000)2741-2754.
[5] I. Pigeot, The bootstrap percentile in Food and Drug Administration Regulations for bioequivalence assessment. Drug information Journal, 35(2001)1445-1453.
[6] J. P. Wan, K. S. Zhang, H. Chen, The bootstrap and Bayesian bootstrap method in assessing bioequivalence. Chaos, Solitons and Fractals, 41(2009)2246-2249.
[7] B. Efron, Bootstrap methods: another look at the jackknife. The Annals of Statistics, 7(1979)1-26.
[8] K. Singh, On the asymptotic accuracy of Efron-s bootstrap. The Annals of Statistics, 9(1981)1187-1195.
[9] P. J. Bickel, and D. A. Freedman, Some asymptotic theory for the bootstrap. The Annals of Statistics, 9(1981)1196-1217.
[10] P. Hall, The Bootstrap and Edgeworth Expansion. New York: Springer,1992.
[11] D. B. Rubin, The Bayesian bootstrap. The Annals of Statistics, 9(1981)130-134.
[12] N. Ting, R. K. Burdick, F. A. Graybill, S. Jeyaratnam and T.-F. C. Lu, Confidence intervals on linear combinations of variance components that are unrestricted in sign. Journal of Statistical Computation and Simulation, 35(1990)135-143.
[13] Y. H. Lee, J. Shao, S. C. Chow, Modified large-sample confidence intervals for linear combinations of variance components: extension, theory, and application. Journal of the American Statistical Association, 99(2004)467-478.