RESUMEN
The Japan Bioanalysis Forum Symposium was held on 12-14 February 2019 (Yokohama, Japan), in celebration of its 10th anniversary, and over 370 participants from pharmaceutical industries, contractors, academia and regulatory authorities from home and abroad came together in Yokohama. The 3-day symposium particularly aimed to foster collaboration with the scientists surrounding bioanalysts, according to the theme 'Open to the Public.' The symposium also included a broad range of pioneering programs, such as lectures by speakers from DMPK/metabolomics fields, discussions of future bioanalysis and poster presentations by publicly offered presenters as well as the regular ones we had organized. This report summarizes the major topics as a conference report.
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Pruebas de Química Clínica , Biomarcadores/análisis , Interacciones Farmacológicas , JapónRESUMEN
The ninth Japan Bioanalysis Forum symposium took place at tower hall Funabori, Tokyo, Japan, between 6 and 8 February, 2018. Bioanalytical scientists from the pharmaceutical industry, CROs, academia and regulatory bodies had many meaningful and relevant discussions on current topics of interest in bioanalysis. The 3-day symposium featured updated perspectives and experiences on regulated bioanalysis of small and large molecules, biomarker measurement and assessment of immunogenicity, as well as new areas of bioanalytical validation such as quantitative polymerase chain reaction(qPCR) and flow cytometry. There were over 260 participants from six countries, with 23 oral and 11 poster presentations, including the outcomes of Japan Bioanalysis Forum discussion groups. This report summarizes the major discussion topics from the conference.
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Técnicas de Química Analítica , Métodos Analíticos de la Preparación de la Muestra , Anticuerpos/análisis , Anticuerpos/uso terapéutico , Cromatografía Liquida , Descubrimiento de Drogas , Humanos , Japón , Espectrometría de MasasRESUMEN
The 8th Japan Bioanalysis Forum symposium, the Tower Hall Funabori, Tokyo, Japan, 8-9 February 2017 The 8th Japan Bioanalysis Forum (JBF) symposium was successfully held between 8 and 9 February 2017 at the Tower Hall Funabori, Tokyo, Japan. In total, 24 speakers from Japan, USA and Europe gave presentations regarding the immunogenicity of biopharmaceuticals, ICH S3A Q&A microsampling, ICH M10 bioanalytical method validation, large molecule analysis through LC-MS, auditing activities for bioanalysis and biomarker bioanalysis. Achievements regarding eight diverse themes were also shared by Japan Bioanalysis Forum discussion groups. Over 300 scientists from regulatory agencies, industry and academia actively took part in discussions during the symposium. This article provides the highlights of all the topics discussed in this symposium.
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Biomarcadores/análisis , Factores Biológicos/inmunología , Cromatografía Líquida de Alta Presión , Regulación Gubernamental , Japón , Espectrometría de MasasRESUMEN
Tower Hall Funabori, Tokyo, Japan, 9-10 March 2016 At the 7th Japan Bioanalysis Forum symposium, bioanalytical methods and processes were discussed with authorities after the issuing of bioanalytical method validation guidelines (EMA and Japanese Ministry of Health, Labour and Welfare) and draft guidance (US FDA). Method establishment and bioanalysis of biomarkers were discussed with a focus on scientific validation. Bioanalytical methods for antibody-drug conjugates, the potential of MS imaging and microsampling activity in drug development were introduced. Discussion groups presented and openly discussed their results with about 300 attendees. This manuscript provides an overview of the highlights of the symposium.