FDA Raises the Bar in Bioanalytical Method Validation

Jun 4, 2014

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 pharmacokinetic analysis of drugs and their metabolites in clinical trials. A revised ...

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Risk-based Monitoring: Roundtable Discussion

Jun 4, 2014

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 many years. Ashok Ghone of MakroCare, Sandra Sather of Clinical Pathways LLC, Sue Fitzpatrick ...

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