FDA acceptance on software R [Software]

posted by d_labes  – Berlin, Germany, 2013-08-16 10:27 (4675 d 12:44 ago) – Posting: # 11292
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Dear Nirali,

I myself have no sure experience since seldom worked for an FDA submission and always stuck with SAS. Additional said sure is a term which should be avoided in the context of regulatory acceptance :cool:. Have a look at ElMaestros signature.

But have a look at this blog "Analyzing clinical trial data with R" or this blog and the documents linked there to get some valuable informations about that topic from an R-viewpoint.

See also "Using R: Perspectives of a FDA Statistical RevieweR" to get the key message "The Food and Drug Administration does not endorse or require use of any specific software".

Hope this helps.

Regards,

Detlew

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