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No. Author Title Journal Vol / No. Page Year
1 米山智城、井上則子、立木秀尚、富樫一天、中山聡、工藤喬、清水久夫、香取典子 日本におけるバイオアナリシス分析法バリデーションの実施に関する指針（バイオアナリシスフォーラム素案）について 医薬品医療機器レギュラトリーサイエンス誌 Vol. 43, No. 8 750 – 760 2012
2 Mami Imazato-Hirano, Yoshitaka Taniguchi, Masaaki Kakehi, Yoji Kuze, Takahiro Nakamura, Yoshiyuki Minamide, Kazuhiro Miya, Jun Hosogi, Masataka Katashima, Kotaro Maekawa, Haruhiro Okuda, Shingo Niimi, Nana Kawasaki, Akiko Ishii-Watabe & Noriko Katori Japanese bioanalytical method validation guideline: the world's first regulatory guideline dedicated to ligand-binding assays Bioanalysis Vol 7, No. 9 1151–1156 2015
3 橋井則貴、鵜藤雅裕、大津善明、加藤 望、合田竜弥、後藤理恵子、清水久夫、高村不二子、星野雅輝、間渕雅成、山口 建、石井明子、香取典子 液体クロマトグラフィー／質量分析を利用した抗体医薬品の血中薬物濃度測定 Chromatography Vol. 39, No. 1 7-19 2018
4 Akiko Ishii-Watabe, Hiroko Shibata, Kazuko Nishimura, Jun Hosogi, Muneo Aoyama, Kazuhiro Nishimiya & Yoshiro Saito Immunogenicity of therapeutic protein products: current considerations for anti-drug antibody assay in Japan Bioanalysis VOL. 10, NO. 2 95-105 2017
5 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 Elucidation of the statistical factors that influence anti-drug antibody cut point setting through a multi-laboratory study Bioanalysis VOL. 11, NO. 6 509-524 2019
6 Yoshiaki Ohtsu, Seiji Tanaka, Harue Igarashi, Masaaki Kakehi, Tamiki Mori, Takahiro Nakamura, Rui Ohashi, Hiroyuki Shimizu, Yutaka Yasuda, Takashige Okayama, Hiroyuki Kakuo, Hiroyuki Yokoi, Mizuki Horiuchi, Masataka Katashima, Ryosuke Nakamura, Kosuke Saito & Yoshiro Saito Analytical method validation for biomarkers as a drug development tool: points to consider Bioanalysis VOL. 13, NO. 18 1379-1389 2021