Clinical Trial Research
New clinical trial research study findings recently were reported by researchers at Pfizer Inc.
Published in Medical Letter on the CDC and FDA, March 14th, 2010
Investigators publish new data in the report 'A guidance for renal biomarker lead optimization and use in translational pharmacodynamics.' According to recent research from the United States, "Guidance for the use of biomarkers in pharmaceutical development and clinical trial optimization will reduce developmental cycle time. A 'fit-for-purpose' guidance for biomarker use is considered herein when the same biomarker is applied in very different contexts in drug development and after regulatory approval."
"Recent approved use of renal safety biomarkers in Good Laboratory Practice studies lacks sufficient guidance for the use of these markers across the drug development...
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