Preparation of Guideline for Bioanalytical Method ...

1 Preparation of Guideline for Bioanalytical Method Validation in Japan BMV 2nd JBF SymposiumMarch 8, 2012 Tomoki Yoneyama, Noriko Inoue, Hidehisa Tachiki, Kazutaka Togashi, Akira Nakayama and Noriko KatoriJapan Bioanalysis ForumJapan Bioanalysis ForumFor attendees from outside Japan This presentation materials are written in JAPANESE considering the nature of the topic addressed. Thank you for your patience and kind understanding. In the future, the BMV Guideline in Japan will be issued in English as well. 2nd JBF Symposium | March 8, 20121 Japan Bioanalysis Forum BMV BMV JBF 2nd JBF Symposium | March 8, 20122 Japan Bioanalysis ForumBMV US FDA Guidance for Industry: Bioanalytical Methods Validation (2001) Workshop/Conference Report Quantitative Bioanalytical Method Validation and Implementation: Best Practice for Chromatographic and Ligand Binding Assays (2007) Workshop Report and Follow-Up AAPS Workshop on Current Topics in GLP Bioanalysis.

2 Assay Reproducibility for Incurred Samples Implications of Crystal City Recommendations (2009) EMA Guideline on Bioanalytical Method validation (2011) Establishment of Global Bioanalysis Consortium (GBC) (2010) 2nd JBF Symposium | March 8, 20123 Japan Bioanalysis ForumBMV 1996 TK 1998 2001 2006 Bioanalytical Method Validation (BMV)

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