Abstract
Tower Hall Funabori, Tokyo, Japan, 6–7 March 2014 At the 5th Japan Bioanalysis Forum symposium, distinguished bioanalytical scientists from government and industry commentated on the bioanalytical method validation guidelines/guidance issued by their own regions, including the draft bioanalytical method validation guideline for ligand binding assay by the Japanese Ministry of Health, Labour and Welfare, which was finalized in April 2014. Additionally, the Japan Bioanalysis Forum Discussion Group, in which daily bioanalytical issues/interests were scientifically discussed, picked up five topics, and more than 200 conference attendees openly exchanged their views on a wide range of bioanalytical issues with discussion group members. This manuscript provides an overview of the highlights out of the symposium.
Subject
Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry
Reference16 articles.
1. US Department of Health and Human Services, Food and Drug Administration. Draft Guidance for Industry: Bioanalytical Method Validation (September, 2013). www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM368107.pdf
2. European Medicine Agency. Guideline on bioanalytical method validation. EMEA/CHMP/EWP/192217/2009 (2011). www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf
3. Conference Report: 4th Japan Bioanalysis Forum Symposium: Japanese guidelines on bioanalytical method validation and latest discussion within the Japanese bioanalyst community
Cited by
4 articles.
订阅此论文施引文献
订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献