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rosiglitazone
2009 Jan 11
2
R, clinical trials and the FDA
...n with a presentation entitled Times 'R' A Changing: FDA
Perspectives on Use of "Open Source". A copy of this presentation is
available here:
http://www.fda.gov/cder/Offices/Biostatistics/Bell.pdf
In 2007, during an FDA committee meeting reviewing the safety profile of
Avandia (Rosiglitazone), the internal FDA meta-analysis performed by Joy
Mele, the FDA statistician, was done using R. A copy of this
presentation is available here:
http://www.fda.gov/ohrms/dockets/ac/07/slides/2007-4308s1-05-fda-mele.ppt
Given the high profile nature of drug safety issues today, that R was
used for...