Date:         Tue, 19 Aug 2008 07:41:13 -0700
Reply-To:     Lex Jansen <lexjansen@GMAIL.COM>
Sender:       "SAS(r) Discussion" <SAS-L@LISTSERV.UGA.EDU>
From:         Lex Jansen <lexjansen@GMAIL.COM>
Organization: http://groups.google.com
Subject:      Re: Validating SAS for FDA?
Comments: To: sas-l@uga.edu
Content-Type: text/plain; charset=ISO-8859-1

You might want to look at this draft guidance as well:
http://www.fda.gov/cdrh/osb/guidance/1601.html

Lex Jansen

On Aug 19, 9:46 am, John Uebersax <jsueber...@gmail.com> wrote:
> Mark,
>
> > FDA does accept R though and they are beginning to accept WinBugs.
>
> I just caught this part.  Actually, that's what my post was leading up
> to.  The real issue I'm faced with is convincing project managers to
> allow WinBUGS.
>
> An alternative has been proposed -- to use a SAS macro for MCMC
> estimation.  This makes no sense to me, since it would seem at least
> as difficult to validate this SAS macro as to validate a WinBUGS
> program.
>
> I don't really understand how the FDA could not accept WinBUGS
> results,  I could understand them rejecting a Bayesian analysis, but
> not the WinBUGS program itself.
>
> For what it's worth, my provisional plan is to demonstrate that
> WinBUGS accurately replicates textbook examples, to document this, and
> to place the document on file.
>
> John Uebersax