Evaluation of the uncertainty of a quantitative approach to drug metabolites in the absence of authentic standards

Affiliations

• ¹ Discovery Research Laboratories, Nippon Shinyaku Co., Ltd, 14, Nishinosho-Monguchi-cho, Kisshoin, Minami-ku, Kyoto 601-8550, Japan.
• ² Quantitative Clinical Pharmacology Department, Research & Development Division, Daiichi Sankyo Co, Ltd, 1-2-58, Hiromachi, Shinagawa-ku, Tokyo, 140-8710, Japan.
• ³ Pharmacokinetics & Safety Department, Drug Research Center, Kaken Pharmaceutical Co., Ltd, 301, Gensuke, Fujieda-shi, Shizuoka 426-8646, Japan.
• ⁴ DMPK & Bioanalysis Unit, Tsukuba R&D Supporting Division, Sunplanet Co., Ltd, 5-1-3 Tokodai, Tsukuba-shi, Ibaraki, 300-2635, Japan.
• ⁵ Pharmaceutical Analysis I Section/Clinical Research Section, Zensei Pharmaceutical Co., Ltd, 380 Mita-cho, Kishiwada-shi, Osaka 596-0808, Japan.
• ⁶ Shin Nippon Biomedical Laboratories, Ltd, Pharmacokinetics & Bioanalysis Center, 16-1 Minamiakasaka, Kainan, Wakayama, 642-0017, Japan.
• ⁷ Bio Science & Engineering Laboratory, Research & Development Management Headquarters, Fujifilm Corporation, 577, Ushijima, Kaisei-machi, Ashigarakami-gun, Kanagawa 258-8577, Japan.
• ⁸ Biomedical Analysis Laboratories, Research Division, Toray Research Center, Inc., 10-1, Tebiro 6-chome, Kamakura, Kanagawa, 248-0036 Japan.