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FDA guidance on bioanalytical method validation (May 2001)
In January 2000 a meeting was held in Crystal City, USA, to discuss and update the original ‘Shah’ Paper (1), taking into account recent advancements in bioanalysis (e.g. the widespread use of mass spectrometric detection, large multi-plate/multicolumn runs etc). Following the meeting, a consensus paper was published (2) and, more recently, the FDA has issued a guidance document for industry (3), dealing comprehensively with validation of bioanalytical methods.
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