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Editorial Archive

FDA Raises the Bar in Bioanalytical Method Validation

For many years, the FDA guidance on bioanalytical method validation (BMV), issued by the CDER in 2001, has been the Holy Grail for laboratories which …

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Editorial Archive

Risk-based Monitoring: Roundtable Discussion

A risk-based monitoring (RBM) approach has opened a pathway to the enhanced quality conduct and reporting of clinical study that the industry has been seeking …

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