Is there anywhere online that I can obtain SUPAC guidelines?

tbc said:

Is there anywhere online that I can obtain SUPAC guidelines?

You can chech the website: www.pharmainfo.net
they might have what you are looking for. or check this page

http://pharmainfo.net/Sections+index-req-viewarticle-artid-19-page-1.html

Thank you very much. Just what I was looking for :)

Pharmainfo.net link is changed , Check new one here..


SUPAC guidelines

Thanks :) , I just added the new link to my favorites.

I think the above link is now outdated, and in any case the latest SUPAC (Scale-Up and Post Approval Changes Guidances) guidelines, and offical comments can be obtained from the FDA, (Food and Drug Administration) at http://www.fda.gov

A search of the FDA site will find lots of relevant documents, in English and Spanish. The site wide search is comprehensive and will return news, presentations, minutes of meetings, and FDA responses to issues raised etc. If you are looking for specific regulatory guidence, then there's:

http://www.fda.gov/cder/guidance/index.htm

The key document oftern refered to as "the" SUPAC guidance is
http://www.fda.gov/cder/guidance/supac.htm - SUPAC-IR/MR : Immediate Release and Modified Release Solid Oral Dosage Forms Chemistry, Manufacturing, and Controls (1995)

Some other key SUPAC guidence:

http://www.fda.gov/cder/guidance/1721fnl.pdf - On Manufacturing Equipment

http://www.fda.gov/cder/guidance/1722dft.pdf -Modified Release Solid Oral Dosage Forms (1997)

http://www.fda.gov/cder/guidance/1447fnl.pdf - SUPAC-SS :Nonsterile Semisolid Dosage Forms (1997)

Do post other relevant links to this thread