Date: Fri, 24 May 2002 12:07:52 -0700
Reply-To: Ed C <sandrun@PRODIGY.NET>
Sender: "SAS(r) Discussion" <SAS-L@LISTSERV.UGA.EDU>
From: Ed C <sandrun@PRODIGY.NET>
Subject: Re: About ISS and ISE
In-Reply-To: <4cd6aa7b.0205230905.4b6a6591@posting.google.com>
Content-Type: text/plain; charset="US-ASCII"
Hi Ganesh
The response from Greg Woolridge is right on. You can't define ISS and
ISE easily, and the best way to learn is to be involved in the process.
The decisions being implemented involve the clinical organization as a
whole. When I attempted to explain ISS and ISE to a group once, it was
most certainly easy to accuse me of over-generalization. From a
programmer's perspective, data from multiple studies for the same study
drug must be combined to present pooled reports of safety and efficacy.
Certain elements of the experience with the study drug will warrant
pooled reporting; so not all safety and efficacy reports from the
individual studies are required.
From my limited understanding--the question to be asked is how is the
study drug doing against the class of drugs it belongs to (usually
compared to the market leader/s). Is the efficacy profile much better
without compromising safety? Are there any troubling areas that may
affect how well this drug does in the market that may compromise its
benefits? Check a drug insert (cough suppressants for example) and you
will see these concerns. If you are working with generics, then the
question is not to show improvement but equivalence with existing drugs
in the same class.
HTH.
Ed C.
http://www.coronadoviews.com
-----Original Message-----
From: SAS(r) Discussion [mailto:SAS-L@LISTSERV.UGA.EDU] On Behalf Of
Ganesh Tamarana
Sent: Thursday, May 23, 2002 10:06 AM
To: SAS-L@LISTSERV.UGA.EDU
Subject: About ISS and ISE
Can any one please help me where can i find the information about ISS
and ISE using sas programing.Can help can be appreciated. Regards,
Ganesh
