Proposal for risk-based scientific approach on full and partial validation for general changes in bioanalytical method
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The guidance and several guidelines on bioanalytical method validation, which were issued by the US FDA, EMA and Ministry of Health, Labour and Welfare, list the ‘full’ validation parameters; however, none of these provide any details for ‘partial’ validation. Japan Bioanalysis Forum approved a total of three annual discussion groups from 2012 to 2014. In the discussion groups, members from pharmaceutical companies and contract research organizations discussed the details of partial validation from a risk assessment viewpoint based on surveys focusing on bioanalysis of small molecules using LC−MS/MS in Japan. This manuscript presents perspectives and recommendations for most conceivable changes...
