Re: NONMEM

From: "A.J. Rossini" blindglobe@gmail.com Subject: Re: [NMusers] NONMEM Date: Fri, 15 Sep 2006 21:13:44 +0200 On 9/15/06, Mark Sale - Next Level Solutions mark@nextlevelsolns.com wrote: <-- lots of comments deleted --> > Part of the reason that this role > hasn't been fully embraced everywhere, (IMHO) is that they are trying > to wrest control of study design away from stats (and others). Methods > to optimize phase III trials are new turf - we wouldn't have to fight > anyone for it, it really is very complimentary to stats - since it > requires their methods to implement. Why need to wrestle anything from stats? Any decent M&S group ought to have a few statisticians around... (speaking from the Novartis M&S viewpoint, where I'm in the statistics subgroup...). More seriously, this IS a critical problem -- there are general design principles for PK sampling design on the programmatic level, i.e. akin to the "adaptive designs" work that more traditional stats groups have been working on. Part of that will be thinking through the range of "critical path" questions that PK sampling might answer, and being a bayesian (and PopKin scientist) about it, leveraging compound family and indication/pathway knowledge about the challenges that could be faced. Analysis is one thing, but design, now that is completely different. And especially working the patterns, i.e. "given models X through Z at Ph I with dense sampling, which resulted in sparse sampling design W for Ph II and PhIb trials which were fit to models X1-- Z1, what does the range of reasonable models suggest that we should use for sampling at Ph III?" (i.e. design using the previous work, or even more interesting, the trajectory of previous work). After all, as I used to say when I was a biostat/stat prof, "nothing like a bad design or sloppy operations to generate another PhD thesis...". But getting the design right, sigh, that's contextual and hard. best, -tony blindglobe@gmail.com Muttenz, Switzerland. "Commit early,commit often, and commit in a repository from which we can easily roll-back your mistakes" (AJR, 4Jan05). _______________________________________________________