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Bioanalysis. 2018 Oct;10(19):1553-1556. doi: 10.4155/bio-2018-0217.

Evaluating exposure using confidence intervals: implication in tiered quantitation of metabolites for safety risks.

Bioanalysis

Makoto Niwa, Takuho Ishii, Keita Ono, Saori Kuriyama, Naoko Nakai, Shinya Hosaka, Tsuyoshi Mayumi, Yutaka Yasuda, Tatsuya Yamakawa

Affiliations

  1. Pharmaceutical Research Laboratories, Nippon Kayaku Co., Ltd., 3-31-12, Kita-ku, Tokyo 115-0042, Japan.
  2. Bioanalysis Unit, Sunplanet Co., Ltd., 5-1-3, Tokodai, Tsukuba-shi, Ibaraki 300-2635, Japan.
  3. Pharmacokinetics Research Laboratories, Taiho Pharmaceutical Co., Ltd., 3, Okubo, Tsukuba, Ibaraki 300-2611, Japan.
  4. Discovery Research Laboratories, Nippon Shinyaku Co., Ltd., 14, Nishinosho-Monguchi-cho, Kisshoin, Minami-ku, Kyoto 601-8550, Japan.
  5. Quantitative Clinical Phamacology Department, Research & Development Division, Daiichi Sankyo Co., Ltd., 1-2-58, Hiromachi, Shinagawa-ku, Tokyo 140-8710, Japan.
  6. Shizuoka Research Center, Kaken Pharmaceutical Co., Ltd., 301, Gensuke Fujieda-shi, Shizuoka 426-8646, Japan.
  7. Zensei Pharmaceutical Co., Ltd., 380 Mita-cho, Kishiwada-shi, Osaka, 596-0808, Japan.
  8. Biomedical Analysis Laboratories, Toray Research Center, Inc., 10-1, Tebiro 6-chome, Kamakura, Kanagawa, 248-0036, Japan.
  9. Fujifilm Corporation, 577, Ushijima, Kaisei-machi, Ashigarakami-gun, Kanagawa 258-8577, Japan.

PMID: 30295549 DOI: 10.4155/bio-2018-0217

[No abstract available.]

Keywords: confidence interval; metabolite quantitation; tiered approach

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