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FDA Biomarker Qualification Group Extends License of GVK GOBIOM Database

The US FDA's biomarker qualification group has extended license of the GVK Biosciences clinical biomarker database (GOBIOM).

The GOBIOM database assists FDA in its biomarker qualification process by providing most recent information on all the clinically evaluated, exploratory and preclinical biomarkers reported in a range of clinical and preclinical studies.

GVK Biosciences informatics, sales and marketing, vice president Sreeni Devidas said the association with the FDA was helpful in developing the GOBIOM safety biomarker content.

"The interconnectivity between organ toxicities to the drug, dose and population was developed with equal emphasis on its preclinical qualification," Devidas added.

"Biomarker analysis tools were integrated into the database in a manner that has facilitated the user to make a comparative analysis between the biomarkers of their interest."

GOBIOM contains information related to 20,000 biochemical, genomic, imaging, metabolite, cellular and physiological biomarkers.

The data base also provides multiple data points concerning experimental, analytical, clinical and statistical data with qualifications under diverse medical interference, according to GVK.

Source: http://itsoftware.pharmaceutical-business-review.com/news/fda-biomarker-qualification-group-extends-license-of-gvk-gobiom-database-050213
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