Discussion Group

Discussion Group

No. Author Title Journal Vol / No. Page Year
1 Kazuaki Sakai, Akira Wakamatsu & Takahiko Oosumi 生体試料中薬物濃度分析における標準溶液の調製方法 Recommended Methods for the Preparation of Standard Solutions : To Provide a Highly Reliable Results in Bioanalysis (Japanese) Bunseki 2015-3 98-105 2015
2 Makoto Niwa、Tkahide Uchimura, Nozomu Koseki, Masahiro Satsukawa, Yoshitaka Hashimoro, Tsuyosi Mayumi, Yutaka Yasuda & Hiroyuki Yokoi 医薬品研究開発における代謝物定量法の段階的アプローチ 　～バイオアナリシスフォーラムディスカッショングループDG2013-03における議論からの考察～ (Japanese) Pharmaceutical and medical device regulatory science Vol 46, No.5 330～341 2015
3 Keiko Nakai, Hiroshi Kamimori, Akemi Nagao & Akira Nakayama 生体試料中薬物濃度分析法のパーシャルバリデーションに関する議論—分析装置変更の場合を対象として— (Japanese) Journal of the Pharmaceutical Society of Japan Vol. 135, No 11 1317-1324 2015
4 Makoto Niwa, Takahide Uchimura, Nozomu Koseki, Masahiro Satsukawa, Yoshitaka Hashimoto, Tsuyoshi Mayumi, Yutaka Yasuda & Hiroyuki Yokoi Tiered approach to metabolite quantification: regional practices reviewed by Japan Bioanalysis Forum discussion group Bioanalysis Vol. 7, No. 8 935–938 2015
5 Makoto Niwa, Nozomu Koseki, Yoshitaka Hashimoto, Tsuyoshi Mayumi, Naohiro Nishimura, Masahiro Satsukawa, Takahide Uchimura, Yutaka Yasuda & Hiroyuki Yokoi Survey on the tiered approach for Japanese bioanalysts operated by Japan bioanalysis forum DG2014-09 Bioanalysis Vol. 8, No. 2 93–98 2016
6 Nozomu Koseki, Hiroko Ashizawa, Takuho Ishii, Takahide Uchimura, Keita Ono, Saori Kuriyama, Akiko Toda, Kuretake Soejima, Naoko Nakai, Naohiro Nishimura, Tsuyoshi Mayumi, Yutaka Yasuda, Tatsuya Yamakawa & Makoto Niwa Giving consideration to scientific validation in Japanese drug application by Japan Bioanalysis Forum discussion group Bioanalysis Vol. 9, No. 13 963–968 2017
7 Noboru Tanaka, Kenta Kadotsuji, Michi Kitano, Satomi Sasahara, Hiroyuki Shimizu, Masako Soma, Fujiko Takamura, Tomohiko Hanada, Jun Hosogi, Tatsuki Nomura, Kazuhiro Miya, Hiroe Miyamoto & Kenichi Ymamoto 医薬品開発における抗薬物抗体分析の現状と課題 (Japanese) Pharmaceutical and Medical Device Regulatory Science Vol. 48, No. 5 282‐291 2017
8 Ayumi Mochizuki, Katsunori Ieki, Hiroshi Kamimori, Akemi Nagao, Keiko Nakai, Akira Nakayama & Eitaro Nanba Proposal for risk-based scientific approach on full and partial validation for general changes in bioanalytical method Bioanalysis Vol. 10, No. 8 577-586 2018
9 Akira Wakamatsu, Shoko Ochiai, Eiko Suzuki, Yoshinobu Yokota, Midori Ochiai, Yosuke Kotani, Satomi Sasahara, Keita Nakanaga, Yuki Hashimoto, Satoko Ueno, Nozomu Kato, Satoshi Kawada, Jun Hayakawa, Eiichi Shimada, Shinya Horita & Kazuaki Sakai Proposed selection strategy of surrogate matrix to quantify endogenous substances by Japan Bioanalysis Forum DG2015-15 Bioanalysis Vol. 10, No. 17 1349-1360 2018
10 Niwa M, Ishii T, Ono K, Kuriyama S, Nakai N, Hosaka S, Mayumi T, Yasuda Y, Yamakawa T. Evaluating exposure using confidence intervals: implication in tiered quantitation of metabolites for safety risks. Bioanalysis Vol. 10, No. 19 1553-1556 2018
11 Makoto Niwa, Naoko Nakai, Shinya Hosaka , Takuho Ishii , Tsuyoshi Mayumi , Ayumi Ueda , Tatsuya Yamakawa , Yutaka Yasuda Evaluation of the Uncertainty of a Quantitative Approach to Drug Metabolites in the Absence of Authentic Standards Bioanalysis Vol. 12, No. 1 7 - 10 2020
12 Niwa M, Kondo A, Shibutani E, Tsuruta A, Shimada E, Hirata S, Fujino N, Maruyama S, Yagi R, Nishida H, Yoshimatsu H Handling unstable analytes: literature review and expert panel survey by the Japan Bioanalysis Forum Discussion Group. Bioanalysis Vol. 14, No. 3 169-185 2021