Estimating the incremental net health benefit of requirements for cardiovascular risk evaluation for diabetes therapies
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چکیده
منابع مشابه
Estimating the incremental net health benefit of requirements for cardiovascular risk evaluation for diabetes therapies
PURPOSE To evaluate the advantages and disadvantages of pre-approval requirements for safety data to detect cardiovascular (CV) risk contained in the December 2008 U.S. Food and Drug Administration (FDA) guidance for developing type 2 diabetes drugs compared with the February 2008 FDA draft guidance from the perspective of diabetes population health. METHODS We applied the incremental net hea...
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ژورنال
عنوان ژورنال: Pharmacoepidemiology and Drug Safety
سال: 2014
ISSN: 1053-8569,1099-1557
DOI: 10.1002/pds.3559