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Date:   Wed, 20 Aug 2008 16:28:36 -0700
Reply-To:   Stephen McDaniel <stephen@STEPHENMCDANIEL.US>
Sender:   "SAS(r) Discussion" <SAS-L@LISTSERV.UGA.EDU>
From:   Stephen McDaniel <stephen@STEPHENMCDANIEL.US>
Subject:   Re: Validating SAS for FDA?
Comments:   To: ohri2007@gmail.com
In-Reply-To:   <4bc14e460808200926y1a6e248bx8afc254b608d13b6@mail.gmail.com>
Content-Type:   text/plain; charset="UTF-8"

A very long list is used in submissions, from simple stats, t-tests, sample size calculations, power analysis, regression, ANOVA, non-parametric techniques (chi square, CMH, etc), monte carlo simulations, survival analysis, etc. This is why there are whole Masters and PhD programs just around Biostats... I left off design for early studies, pharmacoeconomic analysis, etc.

Best, Stephen

-----Original Message----- From: ohri2007@gmail.com [mailto:ohri2007@gmail.com] Sent: Wednesday, August 20, 2008 9:27 AM To: Stephen McDaniel Cc: SAS-L@listserv.uga.edu Subject: Re: Validating SAS for FDA?

Just what specific statistical function does the clinical pharma industry use ( eg means ,mode, regression etc)

On 8/20/08, Stephen McDaniel <stephen@stephenmcdaniel.us> wrote: > I remember way back in the late 90's when I worked for Oracle with the > Oracle Clinical consulting team... This is a product meant for managing > clinical trials data for pharma's. The main product manual prominently said > on page one something to the effect, "... not for use in nuclear, aerospace, > or medical applications..., any use in this realm is explicitly not under > warranty and Oracle can't be held accountable for the precise standards > needed for these types of applications..." or something to that effect. > > Clients loved it when I pointed out that their multi-million dollar software > package stated this in the main manual. Of course, many companies use it > for submissions. Ultimately, the FDA holds the pharma accountable, not the > software maker. That said, if they saw consistent problems with an > application, they might be much harder on any pharma using the app, > ultimately hurting the software company via lower sales and discount demands > by the customers. > > Regards, > Stephen > > On Wed, Aug 20, 2008 at 9:00 AM, Mary <mlhoward@avalon.net> wrote: > >> They might want to change the name...I can't see the FDA as being wild >> about verifying that software with "BUGS" as part of the name is actually >> free of bugs! >> >> -Mary >> ----- Original Message ----- >> From: Kevin Viel >> To: SAS-L@LISTSERV.UGA.EDU >> Sent: Wednesday, August 20, 2008 10:47 AM >> Subject: Re: Validating SAS for FDA? >> >> >> >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. >> >> I am a bit removed from that field, but why turn to textbook examples >> instead of simulating the data? >> >> -Kevin >> >

-- Regards,

Ajay Ohri http://tinyurl.com/liajayohri


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