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• W4319461906 abstract "BioanalysisVol. 14, No. 24 CommentaryPitfalls in bioanalytical work with a Japanese CRO or sponsor: from a project risk management perspectiveMakoto Niwa, Yoshiaki Ohtsu & Noriko KatoriMakoto Niwa *Author for correspondence: E-mail Address: mak.niwa@po.nippon-shinyaku.co.jphttps://orcid.org/0000-0002-2355-1222Nippon Shinyaku Co., Ltd, Kisshoin-Nishinosho-Monguchicho, Minami-ku, Kyoto, Kyoto, 601-8550, JapanSearch for more papers by this author, Yoshiaki Ohtsu https://orcid.org/0000-0003-0494-5717Kyowa Kirin Co., Ltd, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8731, JapanSearch for more papers by this author & Noriko KatoriNational Institute of Health Sciences, Tonomachi, Kawasaki, Kanagawa, 210-9501, JapanSearch for more papers by this authorPublished Online:7 Feb 2023https://doi.org/10.4155/bio-2022-0224AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInReddit View articleKeywords: bioanalytical regulationdrug approvalglobal drug developmentoutsourcingpartnershipReferences1. Cowan KJ. On assay robustness: the importance of early determination and science-driven decision-making. Bioanalysis 5(11), 1317–1319 (2013).Link, CAS, Google Scholar2. Woolf EJ. Perspectives on the draft ICH-M10 guidance: an interview with Eric J Woolf. Bioanalysis 11(15), 1387–1388 (2019).Link, Google Scholar3. Londhe V, Rajadhyaksha M. Pertinence of microsampling in various nonclinical and clinical studies: the ICH perspective. Bioanalysis 14(17), 1137–1139 (2022).Link, CAS, Google Scholar4. Igarashi H, Koseki N, Arakawa T. The Japan Bioanalysis Forum (JBF): the past 8 years and future perspective. Bioanalysis 11(7), 611–617 (2019).Link, CAS, Google Scholar5. Japan Bioanalysis Forum. Japan Bioanalysis Forum Website (2022). http://bioanalysisforum.jp/en/Google Scholar6. Ministry of Health, Labour and Welfare. Nonclinical pharmacokinetics guideline, 26 June 1998 [Japanese] (2022). www.mhlw.go.jp/web/t_doc?dataId=00ta7534&dataType=1&pageNo=1Google Scholar7. Ministry of Health, Labour and Welfare. Guideline on Bioanalytical Method Validation in Pharmaceutical Development, 11 July 2013 (2022). www.nihs.go.jp/drug/BMV/250913_BMV-GL_E.pdfGoogle Scholar8. Ministry of Health, Labour and Welfare. Guideline on Bioanalytical Method (Ligand Binding Assay) Validation in Pharmaceutical Development, 1st April 2014 (2022). www.nihs.go.jp/drug/BMV/260530_LBA-GL_E.pdfGoogle Scholar9. Ministry of Health, Labour and Welfare. Clinical Pharmacokinetics Studies, 1 June 2001 [Japanese] (2022). www.pmda.go.jp/files/000206738.pdfGoogle ScholarFiguresReferencesRelatedDetails Vol. 14, No. 24 Follow us on social media for the latest updates Metrics Downloaded 72 times History Received 30 November 2022 Accepted 19 January 2023 Published online 7 February 2023 Published in print December 2022 Information© 2023 Newlands PressKeywordsbioanalytical regulationdrug approvalglobal drug developmentoutsourcingpartnershipAuthor contributionsConception of the work, idea development, drafting and revision of manuscript, approval of manuscript for submission and agreement to be accountable for all aspects of the work: M Niwa, Y Ohtsu, N Katori.AcknowledgmentsThe authors thank Japan Bioanalysis Forum (JBF) steering committee members for supporting the discussion on this issue and reviewing the manuscript. This manuscript was produced as a part of the JBF task force activity for disseminating regional information.Financial & competing interests disclosureSome of the authors have been employed by pharmaceutical companies. 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" @default.
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