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Volume 16 Issue 4
Discovery Park: Wed 13 November 2024, 10:35
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FDA Raises the Bar in Bioanalytical Method Validation
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 deal with the ph...
4 June 2014 Editorial Archive | Regulatory V6 I3 | Volume 6 Issue 3
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Risk-based Monitoring: Roundtable Discussion
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 for man...
4 June 2014 Editorial Archive | Regulatory V6 I3 | Volume 6 Issue 3
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Catalyst: Fri 8 November 2024, 14:16
Biosynth: Wed 13 November 2024, 10:18

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