You might want to look at this draft guidance as well:
On Aug 19, 9:46 am, John Uebersax <jsueber...@gmail.com> wrote:
> > 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
> 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