Search Results - "Kyle, Robert F."

A Pharmacovigilance Signaling System Based on FDA Regulatory Action and Post-Marketing Adverse Event Reports by Hoffman, Keith B., Dimbil, Mo, Tatonetti, Nicholas P., Kyle, Robert F.

“…Introduction Many serious drug adverse events (AEs) only manifest well after regulatory approval. Therefore, the development of signaling methods to use with…”
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A Drug Safety Rating System Based on Postmarketing Costs Associated with Adverse Events and Patient Outcomes by Hoffman, Keith B, Dimbil, Mo, Kyle, Robert F, Tatonetti, Nicholas P, Erdman, Colin B, Demakas, Andrea, Chen, Dingguo, Overstreet, Brian M

“…Given the multiple limitations associated with relatively homogeneous preapproval clinical trials, inadequate data disclosures, slow reaction times from…”
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