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news.GVK Biosciences (GVK BIO) has extended license of its Clinical Biomarker Database (GOBIOM) to the Biomarker Qualification Group of the US Food and Drug Administration (FDA).
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According to GVK BIO, GOBIOM database, which has the latest and updated information on all the biomarkers reported in various clinical and preclinical studies, will be of use to USFDA in its Biomarker Qualification process.
GOBIOM contains information on 12,000 biomarkers comprising of biochemical, genomic, imaging, metabolite, cellular and physiological markers with multiple data points covering experimental, analytical, clinical and statistical data with their qualifications under different medical interventions.
Informatics Sales and Marketing vice president Sreeni Devidas said the interconnectivity between the organ toxicities to the drug, dose and population was developed with equal emphasis on its preclinical qualification.
"Biomarker analysis tools were integrated into the database such that the user can make comparative analysis between the biomarkers of their interest,"Devidas said.