Re: some issues about NONMEM

From: Diane R Mould - drmould@attglobal.net Subject: Re: [NMusers] some issues about NONMEM Date: 2/11/2004 4:59 PM Dear All I agree that it would be very good to have a repository where all the relevant patches and fixes were readily available for users. The fixes have all been posted to NMUSERS and should be available in the NMUSER archives, but because they are not stored together, they are not easily retrievable. A set of test kits to help the user make certain that the patch was correctly installed and works would also be nice to have as well. As to the quality of work done on a system that has not been upgraded and maintained, I think that it is important to make sure that software is running as well as it can when doing work for regulatory purposes. Some of the patches reported by GLOBOMAX have dealt with errors that could result in substantial differences if runs were done on unpatched systems versus patched systems (e.g. the nested if-then-else bug). I would hope that all the regulatory authorities (not just the FDA) would be making a similar effort to maintain NONMEM to the best standards recommended by the vendor. Therefore, it is important that both sides maintain any system to the best standards possible to minimize potential discrepancies. But perhaps more importantly, this issue has more to do with the analysis and the science then the acceptability of the work by the regulatory authorities. It seems to me that ignoring recommended fixes is just not good science, particularly because many of the patches have dealt with aspects of modeling that many users could encounter during the course of regular work. Diane