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MolecularHealth, FDA Sign Five-Year Pact to Improve Drug Safety Assessment Software


MolecularHealth said this week that it has signed a five-year agreement with the US Food and Drug Administration under which the agency will "evaluate and refine" it's Molecular Analysis of Side Effects, or MASE, software, which supports mechanism-based drug safety assessment and prediction.

Specifically, the FDA's Center for Drug Evaluation and Research will work with MolecularHealth to add molecular and clinical endpoints of regulatory interest into MASE, along with information on patient populations, drug promiscuity, molecular modes of action, and mechanisms of disease.

MolecularHealth, which recently changed its name from Life Biosystems, launched the software-as-a-service offering last month (BI 1/20/2012).

The tool uses information about drug modes of action and the molecular implications of interacting treatments, co-morbidities, and genetic profiles to assess drug safety. It also enables the exploration and analysis of adverse event information from statistical and molecular perspectives and provides analytical and visualization tools to support the detection and validation of drug-related safety issues.

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