Re: [R] "R is not a validated software package.."

From: Wensui Liu <liuwensui_at_gmail.com>
Date: Fri, 08 Jun 2007 11:16:44 -0400

agree with Frank.
as far as I've known, FDA doesn't encourage or discourage the usage of software.

On 6/8/07, Frank E Harrell Jr <f.harrell_at_vanderbilt.edu> wrote:
> Giovanni Parrinello wrote:
> > Dear All,
> > discussing with a statistician of a pharmaceutical company I received
> > this answer about the statistical package that I have planned to use:
> >
> > As R is not a validated software package, we would like to ask if it
> > would rather be possible for you to use SAS, SPSS or another approved
> > statistical software system.
> >
> > Could someone suggest me a 'polite' answer?
> > TIA
> > Giovanni
> >
>
> Search the archives and you'll find a LOT of responses.
>
> Briefly, in my view there are no requirements, just some pharma
> companies that think there are. FDA is required to accepted all
> submissions, and they get some where only Excel was used, or Minitab,
> and lots more. There is a session on this at the upcoming R
> International Users Meeting in Iowa in August. The session will include
> dicussions of federal regulation compliance for R, for those users who
> feel that such compliance is actually needed.
>
> Frank
>
> --
> Frank E Harrell Jr Professor and Chair School of Medicine
> Department of Biostatistics Vanderbilt University
>
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>

-- 
WenSui Liu
A lousy statistician who happens to know a little programming
(http://spaces.msn.com/statcompute/blog)

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Received on Fri 08 Jun 2007 - 15:46:35 GMT

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