Chow, SC, Shao, J, Wang, H. Sample Size Calculation in Clinical Research. 2nd ed. New York: Chapman and Hall/CRC Press/Taylor %26 Francis; 2008.
Lachin, JM, Foulkes, MA. Evaluation of sample size and power for analysis of survival with allowance for nonuniform patient entry, losses to follow‐up, noncompliance, and stratification. Biometrics 1986, 42:507–519.
Lakatos, E. Sample size determination in clinical trials with time‐dependent rates of losses and noncompliance. Control Clin Trials 1986, 7:189–199.
Wang, H, Chow, SC. A practical approach for parallel trials without equal variance assumptions. Stat Med 2002, 21:3137–3151.
Wang, H, Chow, SC, Li, G. On sample size calculation for odds ratio in clinical trials. J Biopharm Stat 2002, 12:471–484.
Chow, SC, Liu, JP. Design and Analysis of Clinical Trials. 2nd ed. New York: John Wiley %26 Sons; 2003.
Schuirmann, DJ. A comparison of the two one‐sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 1987, 15:657–680.
Chow, SC, Liu, JP. Design and Analysis of Bioavailability and Bioequivalence Studies. 3rd ed. New York: Chapman and Hall/CRC Press/Taylor %26 Francis; 2008.
Chow, SC, Shao, J. A note on statistical methods for assessing therapeutic equivalence. Control Clin Trials 2002, 23:515–520.
Berger, RL, Hsu, JC. Bioequivalence trials, intersection‐union tests and equivalence confidence sets (with discussion). Stat Sci 1996, 11:283–319.
Blair, RC, Cole, SR. Two‐sided equivalence testing of the difference between two means. J Mod Appl Stat Methods 2002, 1:139–142.
Westlake, WJ. Symmetric confidence intervals for bioequivalence trials. Biometrics 1976, 32:741–744.
Hsu, JC. Constrained two‐sided simultaneous confidence intervals for multiple comparisons with the best. Ann Stat 1984, 12:1136–1144.
Bofinger, E. Expanded confidence intervals. Communications in Statistics—Theory and Methods 1985, 14:1849–1864.
Bofinger, E. Expanded confidence intervals, one‐sided tests and equivalence testing. J Biopharm Stat 1992, 2:181–188.
Brown, LD, Hwang, JTG, Munk, A. An unbiased test for the bioequivalence problem. Ann Stat 1997, 25:2345–2367.
Bauer, P, Kohne, K. Evaluation of experiments with adaptive interim analysis. Biometrics 1994, 50:1029–1041.
Chang, M. Adaptive design method based on sum of p‐values. Stat Med 2007, 26:2772–2784.
Jennison, C, Turnbull, BW. Group Sequential Tests with Applications to Clinical Trials. London/Boca Raton, FL: Chapman %26 Hall; 2000.
Chow, SC, Chang, M. Adaptive Design Methods in Clinical Trials. New York: Chapman and Hall/CRC Press/Taylor %26 Francis; 2006.
Chow, SC, Shao, J, Hu, OYP. Assessing sensitivity and similarity in bridging studies. J Biopharm Stat 2002, 12:385–400.
Chow, SC, Shao, J. Inference for clinical trials with some protocol amendments. J Biopharm Stat 2005, 15:659–666.
Chow, SC, Chang, M, Pong, A. Statistical consideration of adaptive methods in clinical development. J Biopharm Stat 2005, 15:575–591.
Chow, SC. Controversial Issues in Clinical Trials. New York: Chapman and Hall/CRC Press/Taylor %26 Francis; 2011.
Uesaka, H. Sample size allocation to regions in multiregional trial. J Biopharm Stat 2009, 19:580–594.
Quan, H, Zhao, PL, Zhang, J, Roessner, M, Aizawa, K. Sample size considerations for Japanese patients based on MHLW guidance. Pharm Stat 2010, 9:100–112.
Kawai, N, Stein, C, Komiyama, O, Li, Y. An approach to rationalize partitioning sample size into individual regions in a multiregional trial. Drug Inf J 2008, 42:139–147.
Ko, FS, Tsou, HH, Liu, JP, Hsiao, CF. Sample size determination for a specific region in a multi‐regional trial. J Biopharm Stat 2010, 20:870–885.
Chow, SC. Good statistics practice in drug development and regulatory approval process. Drug Inf J 1997, 31:1157–1166.