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Hui Quan, Zhixing Xu, Meehyung Cho, Yingwen Dong & Nan Jia. (2022) Historical Control Data Borrowing for Noninferiority Assessment. Statistics in Biopharmaceutical Research 14:4, pages 463-472.
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Yongqiang Tang. (2018) Exact and Approximate Power and Sample Size Calculations for Analysis of Covariance in Randomized Clinical Trials With or Without Stratification. Statistics in Biopharmaceutical Research 10:4, pages 274-286.
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Yongqiang Tang. (2018) Sample size for comparing negative binomial rates in noninferiority and equivalence trials with unequal follow-up times. Journal of Biopharmaceutical Statistics 28:3, pages 475-491.
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Seung-Ho Kang. (2016) Avoiding ambiguity with the Type I error rate in noninferiority trials. Journal of Biopharmaceutical Statistics 26:3, pages 452-465.
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Qing Liu, Yulan Li & Katherine Odem-Davis. (2015) On Robustness of Noninferiority Clinical Trial Designs Against Bias, Variability, and Nonconstancy. Journal of Biopharmaceutical Statistics 25:1, pages 206-225.
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Siyan Xu, Kerry Barker, Sandeep Menon & Ralph B. D’Agostino. (2014) Covariate Effect on Constancy Assumption in Noninferiority Clinical Trials. Journal of Biopharmaceutical Statistics 24:6, pages 1173-1189.
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H.M. James Hung & Sue-Jane Wang. (2013) Statistical Considerations for Noninferiority Trial Designs Without Placebo. Statistics in Biopharmaceutical Research 5:3, pages 239-247.
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So-Young Wang & Seung-Ho Kang. (2013) Strength of Evidence of Noninferiority Trials with the Two Confidence Interval Method with Random Margin. Journal of Biopharmaceutical Statistics 23:2, pages 307-321.
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Seung-Ho Kang & Yuman Ryu. (2011) The Adjustment of the Type I Error Rate in Noninferiority Trials with λ-Margin Approach: Each of Two Different New Drugs is Approved with Two Independent Trials with the Same Active Control. Journal of Biopharmaceutical Statistics 21:3, pages 498-510.
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H.M. James Hung & Sue-Jane Wang. (2010) Comment on “PISC Expert Team White Paper: Toward a Consistent Standard of Evidence When Evaluating the Efficacy of an Experimental Treatment From a Randomized Active-Controlled Trial”. Statistics in Biopharmaceutical Research 2:4, pages 532-534.
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Patrick Peterson, Kevin Carroll, Christy Chuang-Stein, Yu-Yun Ho, Qi Jiang, Gang Li, Matilde Sanchez, Rick Sax, Yong-Cheng Wang & Steven Snapinn. (2010) PISC Expert Team White Paper: Toward a Consistent Standard of Evidence When Evaluating the Efficacy of an Experimental Treatment From a Randomized, Active-Controlled Trial. Statistics in Biopharmaceutical Research 2:4, pages 522-531.
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Holger Dette, Matthias Trampisch & Ludwig A. Hothorn. (2009) Robust Designs in Noninferiority Three-Arm Clinical Trials With Presence of Heteroscedasticity. Statistics in Biopharmaceutical Research 1:3, pages 268-278.
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Yi Tsong & Wen-Jen Chen. (2007) Noninferiority Testing Beyond Simple Two-Sample Comparison∗
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Articles from other publishers (18)
Yongqiang Tang. (2020) Score confidence intervals and sample sizes for stratified comparisons of binomial proportions. Statistics in Medicine 39:24, pages 3427-3457.
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Yongqiang Tang. (2018)
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Guoxing SoonZhiwei ZhangYi TsongLei Nie. (2012) Assessing overall evidence from noninferiority trials with shared historical data. Statistics in Medicine 32:14, pages 2349-2363.
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Khadeeja Mohamed, Andrew Embleton & Robert L. Cuffe. (2011) Adjusting for covariates in non-inferiority studies with margins defined as risk differences. Pharmaceutical Statistics 10:5, pages 461-466.
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Sue-Jane Wang & Jeffrey D. Blume. (2011) An evidential approach to non-inferiority clinical trials. Pharmaceutical Statistics 10:5, pages 440-447.
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Seung‐Ho Kang & Yi Tsong. (2010) Strength of evidence of non‐inferiority trials—The adjustment of the type I error rate in non‐inferiority trials with the synthesis method. Statistics in Medicine 29:14, pages 1477-1487.
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H. M. James Hung, Sue-Jane Wang & Robert O'Neill. (2009) Challenges and regulatory experiences with non-inferiority trial design without placebo arm. Biometrical Journal 51:2, pages 324-334.
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Valerie L. Durkalski & Vance W. Berger. (2009) Re-Formulating Non-inferiority Trials as Superiority Trials: The Case of Binary Outcomes. Biometrical Journal 51:1, pages 185-192.
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