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Journal of Biopharmaceutical Statistics|March 20, 2026
Controversial issues in clinical investigation of rare disease drug developmentShein-Chung Chow, Jiayin Zheng
Journal of Biopharmaceutical Statistics|June 2, 2026
Statistical approaches for shelf-life determination of a drug productTengfei Li, Xutong Zhao, Meiyu Shen, et al.
Journal of Biopharmaceutical Statistics|June 5, 2026
Comparison of in-vitro release rates for vaginal systemsMeiyu Shen, Xiaoyu Cai, Vidula Kolhatkar
Journal of Biopharmaceutical Statistics|June 5, 2026
Pivotal trial design considerations for new and next generation cell and gene therapiesPatricia Anderson, Zhenzhen Xu, Evgeny Degtyarev, et al.
Journal of Biopharmaceutical Statistics|June 8, 2026
A framework for joint assessment of a terminal event and a score existing only in the absence of the terminal eventKlaus Kähler Holst, Andreas Nordland, Julie Funch Furberg, et al.
Journal of Biopharmaceutical Statistics|July 18, 2023
A Bayesian phase I-II clinical trial design to find the biological optimal dose on drug combinationZiqing Wang, Jingyi Zhang, Tian Xia, et al.
Journal of Biopharmaceutical Statistics|July 12, 2023
Statistical Considerations and Software for Designing Sequential, Multiple Assignment, Randomized Trials (SMART) with a Survival Final EndpointSasha Kravets, Amy S Ruppert, Sawyer B Jacobson, et al.
Journal of Biopharmaceutical Statistics|June 18, 2023
Statistical considerations for some issues in clinical bridging studies evaluating companion diagnostic devicesChanghong Song, Xiaoqin Xiong, Sunghee Kim, et al.
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