title: Japanese bioanalytical method validation guideline: the world's first regulatory guideline dedicated to ligand-binding assays.
authors.affiliation: 1Novartis Pharma, Toranomon Hills Mori Tower, 23-1, Toranomon 1-chome, Minato-ku, Tokyo 105-6333, Japan.
authors.forename: Mami
authors.initials: M
authors.lastname: Imazato-Hirano
authors.affiliation: 2Toray Research Center, 6-10-1, Tebiro, Kamakura, Kanagawa 248-0036, Japan.
authors.forename: Yoshitaka
authors.initials: Y
authors.lastname: Taniguchi
authors.affiliation: 3Takeda Pharmaceutical, 26-21, Muraoka-Higashi 2-chome, Fujisawa, Kanagawa 251-8555, Japan.
authors.forename: Masaaki
authors.initials: M
authors.lastname: Kakehi
authors.affiliation: 3Takeda Pharmaceutical, 26-21, Muraoka-Higashi 2-chome, Fujisawa, Kanagawa 251-8555, Japan.
authors.forename: Yoji
authors.initials: Y
authors.lastname: Kuze
authors.affiliation: 4Shin Nippon Biomedical Laboratories, 2438 Miyanoura, Kagoshima 891-1394, Japan.
authors.forename: Takahiro
authors.initials: T
authors.lastname: Nakamura
authors.affiliation: 5Shimadzu Techno-Research, 1, Nishinokyo-Shimoaicho, Nakagyo-ku, Kyoto 604-8436, Japan.
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Minamide
authors.affiliation: 6Chugai Pharmaceutical, 200 Kajiwara, Kamakura, Kanagawa 247-8530, Japan.
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Miya
authors.affiliation: 7Kyowa Hakko Kirin, 1188 Shimotogari, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8731, Japan.
authors.forename: Jun
authors.initials: J
authors.lastname: Hosogi
authors.affiliation: 8Astellas Pharma, 2-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo 103-8411, Japan.|9Japan Pharmaceutical Manufacturers Association (JPMA), Drug Evaluation Committee, Torii Nihonbashi Building, 3-4-1 Nihonbashi-Honcho, Chuo-Ku, Tokyo 103-0023, Japan.
authors.forename: Masataka
authors.initials: M
authors.lastname: Katashima
authors.affiliation: 9Japan Pharmaceutical Manufacturers Association (JPMA), Drug Evaluation Committee, Torii Nihonbashi Building, 3-4-1 Nihonbashi-Honcho, Chuo-Ku, Tokyo 103-0023, Japan.|10Hisamitsu Pharmaceutical, 2-4-1, Marunouchi, Chiyoda-ku, Tokyo 100-6330, Japan.
authors.forename: Kotaro
authors.initials: K
authors.lastname: Maekawa
authors.affiliation: 11National Institute of Health Sciences, Kamiyoga 1-18-11, Setagaya-ku, Tokyo 158-8501, Japan.
authors.forename: Haruhiro
authors.initials: H
authors.lastname: Okuda
authors.affiliation: 11National Institute of Health Sciences, Kamiyoga 1-18-11, Setagaya-ku, Tokyo 158-8501, Japan.
authors.forename: Shingo
authors.initials: S
authors.lastname: Niimi
authors.affiliation: 11National Institute of Health Sciences, Kamiyoga 1-18-11, Setagaya-ku, Tokyo 158-8501, Japan.
authors.forename: Nana
authors.initials: N
authors.lastname: Kawasaki
authors.affiliation: 11National Institute of Health Sciences, Kamiyoga 1-18-11, Setagaya-ku, Tokyo 158-8501, Japan.
authors.forename: Akiko
authors.initials: A
authors.lastname: Ishii-Watabe
authors.affiliation: 11National Institute of Health Sciences, Kamiyoga 1-18-11, Setagaya-ku, Tokyo 158-8501, Japan.
authors.forename: Noriko
authors.initials: N
authors.lastname: Katori
mesh_terms: D002623:Chemistry Techniques, Analytical / Q000379:methods* / Q000592:standards; D017408:Guidelines as Topic; D007202:Indicators and Reagents / Q000737:chemistry; D007564:Japan; D008024:Ligands; D012015:Reference Standards; D015203:Reproducibility of Results; D012107:Research Design; D012926:Social Control, Formal
chemical_list: D007202:Indicators and Reagents; D008024:Ligands