A Novel Approach to Testing for Average Bioequivalence Based on Modeling the Within-Period Dependence Structure

References

• Berger, R. L., & Hsu, J. C. (1996). Bioequivalence trials, intersection-union tests and equivalence confidence sets. Statistical Science 11(4):283–302.
   Web of Science ®Google Scholar
• Chinchilli, V. M., & Elswick, R. K. (1997). The multivariate assessment of bioequivalence. Journal of Biopharmaceutical Statistics 7(1):113–123.
   PubMedGoogle Scholar
• Chow, S. C., & Liu, J. P. (2004). Design and Analysis of Clinical Trials: Concepts and Methodologies, 2nd ed. Hoboken, NJ: Wiley-Interscience.
   Google Scholar
• Chow, S. C., & Liu, J. P. (2008). Design and Analysis of Bioavailability and Bioequivalence Studies. Boca Raton, FL: CRC Press.
   Google Scholar
• Cordell, H. J., & Elston, R. C. (1999). Fieller’s theorem and linkage disequilibrium mapping. Genetic Epidemiology 17(4):237–252.
   PubMed Web of Science ®Google Scholar
• Cox, C. (1990). Fieller’s theorem, the likelihood and the delta method. Biometrics 46(3).
   Web of Science ®Google Scholar
• Fai, A. H. T., & Cornelius, P. L. (1996). Approximate F-tests of multiple degree of freedom hypotheses in generalized least squares analyses of unbalanced split-plot experiments. Journal of Statistical Computation and Simulation 54(4):363–378.
   Web of Science ®Google Scholar
• Faraggi, D., Izikson, P., & Reiser, B. (2003). Confidence intervals for the 50 per cent response dose. Statistics in Medicine 22(12):1977–1988.
   PubMed Web of Science ®Google Scholar
• FDA. (2001). Guidance for Industry: Statistical Approaches to Establishing Bioequivalence. Silver Spring, MD: U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER).
   Google Scholar
• Ferron, J., Dailey, R., & Yi, Q. (2002). Effects of misspecifying the first-level error structure in two-level models of change. Multivariate Behavioral Research 37(3):379–403.
   PubMed Web of Science ®Google Scholar
• Gao, F., Thompson, P., Xiong, C., & Miller, J. P. (2006). Analyzing multivariate longitudinal data using SAS. In Proceedings of the Thirty-first Annual SAS Users Group International Conference, pp. 187–731.
   Google Scholar
• Graff-Lonnevig, V., & Browaldh, L. (1990). Twelve hours’ bronchodilating effect of inhaled for-moterol in children with asthma: A double-blind cross-over study versus salbutamol. Clinical & Experimental Allergy 20(4):429–432.
   PubMed Web of Science ®Google Scholar
• Graybill, F. A. (2000). Theory and Application of the Linear Model, 1st ed. North Scituate, MA: Duxbury Press.
   Google Scholar
• Hauschke, D., Steinijans, V. W., & Diletti, E. (1990). A distribution-free procedure for the statistical analysis of bioequivalence studies. International Journal of Clinical Pharmacology, Therapy, and Toxicology 28(2):72–78.
   PubMedGoogle Scholar
• Herson, J. (1975). Fieller’s theorem vs. the delta method for significance intervals for ratios. Journal of Statistical Computation and Simulation 3(3):265–274.
   Google Scholar
• Julious, S. A., & Debarnot, C. A. (2000). Why are pharmacokinetic data summarized by arithmetic means? Journal of Biopharmaceutical Statistics 10(1):55–71.
   PubMedGoogle Scholar
• Kenward, M. G., & Roger, J. H. (1997). Small sample inference for fixed effects from restricted maximum likelihood. Biometrics 53(3):983–997.
   PubMed Web of Science ®Google Scholar
• Keselman, H. J., Algina, J., Kowalchuk, R. K., & Wolfinger, R. D. (1998). A comparison of two approaches for selecting covariance structures in the analysis of repeated measurements. Communications in Statistics–Simulation and Computation 27(3):591–604.
   Web of Science ®Google Scholar
• Lacey, L. F., Keene, O. N., Pritchard, J. F., & Bye, A. (1997). Common noncompartmental pharmacokinetic variables: Are they normally or log-normally distributed? Journal of Biopharmaceutical Statistics 7(1):171–178.
   PubMedGoogle Scholar
• Littell, R. C., Milliken, G. A., Stroup, W. W., Wolfinger, R. D., & Schabenberger, O. (2006). SAS System for Mixed Models., 2nd ed. Cary, NC: SAS Publishing.
   Google Scholar
• Liu, J. P., & Weng, C. S. (1994). Evaluation of log-transformation in assessing bioequivalence. Communications in Statistics – Theory and Methods 23(2):421–434.
   Web of Science ®Google Scholar
• Locke, C. S. (1984). An exact confidence interval from untransformed data for the ratio of two formulation means. Journal of Pharmacokinetics and Pharmacodynamics 12(6):649–655.
   Web of Science ®Google Scholar
• Marston, S. A., & Polli, J. E. (1997). Evaluation of direct curve comparison metrics applied to pharmacokinetic profiles and relative bioavailability and bioequivalence. Pharmaceutical Research 14(10):1363–1369.
   PubMed Web of Science ®Google Scholar
• Mauger, D. T., & Chinchilli, V. M. (2000a). An alternative index for assessing profile similarity in bioequivalence trials. Statistics in Medicine 19(20):2855–2866.
   PubMed Web of Science ®Google Scholar
• Mauger, D. T., & Chinchilli, V. M. (2000b). Profile similarity in bioequivalence trials. Sankhy: The Indian Journal of Statistics, Series B 62(1):149–161.
   Google Scholar
• Patterson, S. D., & Jones, B. (2005). Bioequivalence and Statistics in Clinical Pharmacology. Boca Raton, FL: Chapman and Hall/CRC.
   Google Scholar
• Rescigno, A. (1992). Bioequivalence. Pharmaceutical Research 9(7):925–928.
   PubMed Web of Science ®Google Scholar
• Schuirmann, D. J. (1987). A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. Journal of Pharmacokinetics and Biopharmaceutics 15(6):657–680.
   PubMedGoogle Scholar
• Verbeke, G., & Molenberghs, G. (2000). Linear Mixed Models for Longitudinal Data. New York, NY: Springer Verlag ( June 1, 2000).
   Google Scholar
• Vuorinen, J., & Tuominen, J. (1994). Fieller’s confidence intervals for the ratio of two means in the assessment of average bioequivalence from crossover data. Statistics in Medicine 13(23–24): 2531–2545.
   PubMed Web of Science ®Google Scholar
• Wang, W., Gene Hwang, J. T., & Dasgupta, A. (1999). Statistical tests for multivariate bioequivalence. Biometrika 86(2):395–402.
   Web of Science ®Google Scholar
• Westlake, W. J. (1972). Use of confidence intervals in analysis of comparative bioavailability trials. Journal of Pharmaceutical Sciences 61(8):1340–1341.
   PubMed Web of Science ®Google Scholar
• Willan, A. R., & O’Brien, B. J. (1996). Confidence intervals for cost-effectiveness ratios: An application of Fieller’s theorem. Health Economics 5(4):297–305.
   PubMed Web of Science ®Google Scholar