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Proposal for risk-based scientific approach on full and partial validation for general changes in bioanalytical method.
Mochizuki, Ayumi; Ieki, Katsunori; Kamimori, Hiroshi; Nagao, Akemi; Nakai, Keiko; Nakayama, Akira; Nanba, Eitaro.
Afiliação
  • Mochizuki A; Office of Clinical Pharmacology, Department of Clinical Management, Headquarters of Clinical Development, Otsuka Pharmaceutical Co., Ltd., 3-2-27 Otedori, Chuo-ku, Osaka 540-0021, Japan.
  • Ieki K; Pharmacokinetics & Bioanalysis Center, Shin Nippon Biomedical Laboratories, Ltd., 16-1 Minamiakasaka, Kainan, Wakayama 642-0017, Japan.
  • Kamimori H; Pharmaceutical Research Division, Shionogi & Co., Ltd., 3-1-1 Futaba-cho, Toyonaka, Osaka 561-0825, Japan.
  • Nagao A; Drug Metabolism & Pharmacokinetics Research Laboratories, Central Pharmaceutical Research Institute, Japan Tobacco Inc., 1-1, Murasaki-cho, Takatsuki, Osaka 569-1125, Japan.
  • Nakai K; Corporate Planning Development, Corporate Strategy Division, LSI Medience Corporation, THE KAITEKI Bldg., 13-4, Uchikanda 1-chome, Chiyoda-ku, Tokyo 101-8517, Japan.
  • Nakayama A; Advanced Analytical Science Group, Institute for Innovation, Ajinomoto Co., Inc., 1-1 Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa 210-8681, Japan.
  • Nanba E; Research Division, Chugai Pharmaceutical Co., Ltd., 1-135 Komakado, Gotemba, Shizuoka 412-8513, Japan.
Bioanalysis ; 10(8): 577-586, 2018 Apr 01.
Article em En | MEDLINE | ID: mdl-29633860
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Bioensaio Tipo de estudo: Etiology_studies / Qualitative_research / Risk_factors_studies Limite: Humans Idioma: En Ano de publicação: 2018 Tipo de documento: Article
Texto completo
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XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Bioensaio Tipo de estudo: Etiology_studies / Qualitative_research / Risk_factors_studies Limite: Humans Idioma: En Ano de publicação: 2018 Tipo de documento: Article