Japanese bioanalytical method validation guideline: the world's first regulatory guideline dedicated to ligand-binding assays
2015; Future Science Ltd; Volume: 7; Issue: 9 Linguagem: Inglês
10.4155/bio.15.43
ISSN1757-6199
AutoresMami Imazato-Hirano, Yoshitaka Taniguchi, Masaaki Kakehi, Yoji Kuze, Takahiro Nakamura, Yoshiyuki Minamide, Kazuhiro Miya, Jun Hosogi, Masataka Katashima, Kotaro Maekawa, Haruhiro Okuda, Shingo Niimi, Nana Kawasaki, Akiko Ishii‐Watabe, Noriko Katori,
Tópico(s)Pharmaceutical Economics and Policy
ResumoBioanalysisVol. 7, No. 9 RegulatoryJapanese bioanalytical method validation guideline: the world's first regulatory guideline dedicated to ligand-binding assaysMami Imazato-Hirano, Yoshitaka Taniguchi, Masaaki Kakehi, Yoji Kuze, Takahiro Nakamura, Yoshiyuki Minamide, Kazuhiro Miya, Jun Hosogi, Masataka Katashima, Kotaro Maekawa, Haruhiro Okuda, Shingo Niimi, Nana Kawasaki, Akiko Ishii-Watabe & Noriko KatoriMami Imazato-Hirano Novartis Pharma, Toranomon Hills Mori Tower, 23–1, Toranomon 1-chome, Minato-ku, Tokyo 105–6333, Japan, Yoshitaka Taniguchi Toray Research Center, 6–10–1, Tebiro, Kamakura, Kanagawa 248–0036, Japan, Masaaki Kakehi Takeda Pharmaceutical, 26–21, Muraoka-Higashi 2-chome, Fujisawa, Kanagawa 251–8555, Japan, Yoji Kuze Takeda Pharmaceutical, 26–21, Muraoka-Higashi 2-chome, Fujisawa, Kanagawa 251–8555, Japan, Takahiro Nakamura Shin Nippon Biomedical Laboratories, 2438 Miyanoura, Kagoshima 891–1394, Japan, Yoshiyuki Minamide Shimadzu Techno-Research, 1, Nishinokyo-Shimoaicho, Nakagyo-ku, Kyoto 604–8436, Japan, Kazuhiro Miya Chugai Pharmaceutical, 200 Kajiwara, Kamakura, Kanagawa 247–8530, Japan, Jun Hosogi Kyowa Hakko Kirin, 1188 Shimotogari, Nagaizumi-cho, Sunto-gun, Shizuoka 411–8731, Japan, Masataka Katashima Astellas Pharma, 2–5–1, Nihonbashi-Honcho, Chuo-ku, Tokyo 103–8411, Japan Japan Pharmaceutical Manufacturers Association (JPMA), Drug Evaluation Committee, Torii Nihonbashi Building, 3–4–1 Nihonbashi-Honcho, Chuo-Ku, Tokyo 103–0023, Japan, Kotaro Maekawa Japan Pharmaceutical Manufacturers Association (JPMA), Drug Evaluation Committee, Torii Nihonbashi Building, 3–4–1 Nihonbashi-Honcho, Chuo-Ku, Tokyo 103–0023, Japan Hisamitsu Pharmaceutical, 2–4–1, Marunouchi, Chiyoda-ku, Tokyo 100–6330, Japan, Haruhiro Okuda National Institute of Health Sciences, Kamiyoga 1–18–11, Setagaya-ku, Tokyo 158–8501, Japan, Shingo Niimi National Institute of Health Sciences, Kamiyoga 1–18–11, Setagaya-ku, Tokyo 158–8501, Japan, Nana Kawasaki National Institute of Health Sciences, Kamiyoga 1–18–11, Setagaya-ku, Tokyo 158–8501, Japan, Akiko Ishii-Watabe*Author for correspondence: E-mail Address: watabe@nihs.go.jp National Institute of Health Sciences, Kamiyoga 1–18–11, Setagaya-ku, Tokyo 158–8501, Japan & Noriko Katori National Institute of Health Sciences, Kamiyoga 1–18–11, Setagaya-ku, Tokyo 158–8501, JapanPublished Online:3 Jun 2015https://doi.org/10.4155/bio.15.43AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInReddit View articlePapers of special note have been highlighted as either: • of interest •• of considerable interestReferences1 Japanese Ministry of Health, Labour and Welfare. 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Necessity of parallelism assessment is also discussed.Crossref, Medline, CAS, Google ScholarFiguresReferencesRelatedDetailsCited ByThe effectiveness of quality control samples in pharmaceutical bioanalysisStephen Keller, Jorge Quiroz, Dave Christopher, Enaksha Wickremsinhe, Wanping Geng, Glen Hawthorne, Christopher James, Yvonne Katterle, Wenkui Li, Guowen Liu, Andrew Mayer, Martin Paton, Joseph Pav, Julian Potter, James Vergis, Jonathan Wang, Lucas Westcott-Baker, Eric Woolf & Yongjun Xue4 February 2021 | Bioanalysis, Vol. 13, No. 3Application of automated liquid handling in ligand-binding assay-based bioanalytical method development: the practical considerationsMark Ware, Gopi Shankar, Patrick Breslin & Tong-Yuan Yang21 March 2018 | Bioanalysis, Vol. 10, No. 7Collaborative study using common samples to evaluate the performance of anti-drug antibody assays constructed by different companiesDrug Metabolism and Pharmacokinetics, Vol. 33, No. 2Immunogenicity of therapeutic protein products: current considerations for anti-drug antibody assay in JapanAkiko Ishii-Watabe, Hiroko Shibata, Kazuko Nishimura, Jun Hosogi, Muneo Aoyama, Kazuhiro Nishimiya & Yoshiro Saito15 December 2017 | Bioanalysis, Vol. 10, No. 2 Vol. 7, No. 9 STAY CONNECTED Metrics Downloaded 567 times History Published online 3 June 2015 Published in print May 2015 Information© Future Science LtdAcknowledgementThe authors would like to thank T Mitsuoka (MHLW) for his valuable advice; the members of the JBF for their dedicated contribution; K Sakai (Teijin Pharma, JPMA), H Oiwa (Kyowa Hakko Kirin, JPMA) and Japanese and overseas bioanalysts for their invaluable comments and advice given during the Guideline development.Financial & competing interests disclosureThis work was supported by Grants-in-Aid from the Health and Labour Sciences Research Grants, the Ministry of Health, Labour and Welfare of Japan. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.No writing assistance was utilized in the production of this manuscript.PDF download
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