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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 guidanc...
Autores principales: | Chawla, Anita J, Mytelka, Daniel S, McBride, Stephan D, Nellesen, Dave, Elkins, Benjamin R, Ball, Daniel E, Kalsekar, Anupama, Towse, Adrian, Garrison, Louis P |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BlackWell Publishing Ltd
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4285165/ https://www.ncbi.nlm.nih.gov/pubmed/24892175 http://dx.doi.org/10.1002/pds.3559 |
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