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FDA testing MolecularHealth software to find mechanisms behind drug side effects
Mining for safety mechanisms
By Aaron Bouchie
Senior Writer
Published on
Monday, March 5, 2012
FDA has been quietly test-driving informatics platforms
that include mechanism of action data to complement and augment the agency's
safety surveillance techniques. Most recently, FDA began evaluating MolecularHealth
Inc.'s Molecular Analysis of Side Effects software system, which the
company launched in January.
The collaborations are part of
the agency's mechanism-based drug safety assessment and prediction program,
which was started in 2009 to develop informatics tools to help determine
whether adverse events are mechanistically related to a drug, as well as to
predict whether a compound in clinical trials could cause unexpected adverse
events.
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