topic Re: SAS Macros for FDA in SAS Programming

SAS Macros for FDA

djbateman — Mon, 12 Nov 2012 13:37:00 GMT

I hope this is the most appropriate place to post this questions. I understand that SAS provides SAS programs and macros to the FDA for their analysis of pharmaceutical data. I was referenced to some macros written by Moh-Jee Ng, Division of Biometrics, Center for Drug Evaluation and Research at the FDA. The macros were written on March 9, 1992. The macros should be intended to analyze product stability data. Does anyone know where I can get a hold of those macros for some analyses that we need to send to the FDA? I cannot find anything through a Google search, and I was told that I might have more luck going through SAS than through the FDA.

Re: SAS Macros for FDA

art297 — Mon, 12 Nov 2012 14:09:34 GMT

Is this the one you are looking for?: http://www.crcnetbase.com/doi/abs/10.1201/9781584889069.axb

Re: SAS Macros for FDA

djbateman — Mon, 12 Nov 2012 14:12:48 GMT

I don't know if it is what I am looking for, but I will run with it. Thanks!

Re: SAS Macros for FDA

art297 — Mon, 12 Nov 2012 14:28:52 GMT

Found another one and I think this is the one you were referring to. It is described on page 270 of the pdf and the entire macro is in Appendix B:

http://www.wosco.org/books/Mathematics/Statistical_Design.pdf

Re: SAS Macros for FDA

statz — Mon, 07 Dec 2015 16:02:07 GMT

Hi,
Do you have the SAS macro for stability analysis? can you please send to me? Thanks.