活動実績

ディスカッショングループ

No. Author Title Journal Vol / No. Page Year
1 酒井和明、若松明、大住孝彦 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 ぶんせき 2015-3 98-105 2015
2 丹羽誠、内村隆秀、小関望、薩川正広、橋本義孝、真弓剛、安田穣、横井宏之 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~ 医薬品医療機器レギュラトリーサイエンス Vol 46, No.5 330~341 2015
3 中井 恵子、上森 浩、永尾 明美、中山 聡 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— 薬学雑誌 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 田中 登、角辻 賢太、北野 未知、笹原 里美、清水 浩之、相馬 雅子、高村 不二子、花田 智彦、細木 淳、野村 達希、宮 和弘、宮本 裕恵、山本 健一 医薬品開発における抗薬物抗体分析の現状と課題 医薬品医療機器レギュラトリーサイエンス 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