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Qi Xia, Yi Tsong & Yu-Ting Weng. (2020) Methods and applications of percentile estimation. Journal of Biopharmaceutical Statistics 30:2, pages 267-276.
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Jorge Quiroz, Satrajit Roychoudhury, Thomas Steinmetz & Harry Yang. (2023) Modeling immunogenecity data to establish screening bioassays cut point. Pharmaceutical Statistics 22:6, pages 978-994.
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Jialiang Du, Yalan Yang, Lingling Zhu, Shaoyi Wang, Chuanfei Yu, Chunyu Liu, Caifeng Long, Baowen Chen, Gangling Xu, Linglong Zou & Lan Wang. (2023) Method validation of a bridging immunoassay in combination with acid-dissociation and bead treatment for detection of anti-drug antibody. Heliyon 9:3, pages e13999.
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Özgür Asar, David Bolin, Peter J. Diggle & Jonas Wallin. (2020) Linear mixed effects models for non‐Gaussian continuous repeated measurement data. Journal of the Royal Statistical Society: Series C (Applied Statistics) 69:5, pages 1015-1065.
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Jianchun Zhang, Rosalin HGP Arends, Robert J Kubiak, Lorin K Roskos, Meina Liang, Nancy Lee, Cecil Chi-Keung Chen & Harry Yang. (2020) A new method for identification of outliers in immunogenicity assay cut point data. Journal of Immunological Methods 484-485, pages 112817.
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Kazuko Nishimura, Hiroko Shibata, Muneo Aoyama, Jun Hosogi, Kenta Kadotsuji, Kyoko Minoura, Tamiki Mori, Takahiro Nakamura, Kazuhiro Nishimiya, Tatsuki Nomura, Tetsu Saito, Masako Soma, Hiroki Wakabayashi, Norihisa Sakamoto, Shingo Niimi, Noriko Katori, Yoshiro Saito & Akiko Ishii-Watabe. (2019) Elucidation of the statistical factors that influence anti-drug antibody cut point setting through a multi-laboratory study. Bioanalysis 11:6, pages 509-524.
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Robert J. Kubiak, Jianchun Zhang, Pin Ren, Harry Yang & Lorin K. Roskos. (2018) Excessive outlier removal may result in cut points that are not suitable for immunogenicity assessments. Journal of Immunological Methods 463, pages 105-111.
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Jianchun Zhang, Wenjia Li, Lorin K. Roskos & Harry Yang. (2017) Immunogenicity assay cut point determination using nonparametric tolerance limit. Journal of Immunological Methods 442, pages 29-34.
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