RE: Reporting of interim models in Pop PK Reports

From: Mark Sale - Next Level Solutions mark@nextlevelsolns.com Subject: RE: [NMusers] Reporting of interim models in Pop PK Reports Date: Tue, 18 Jul 2006 11:13:19 -0700 Sorry, but I have to weigh in now. Does "the agency" care about the model building logic? Does anyone? or do we only care if the final model passes some set of reasonableness criteria? Wasn't it Thomas Edison who, after several hundred failed attempts at a light bulb said "No, I've found 200 ways not to make a light bulb". IMHO, even when exercised flawlessly, the "logic" that we use to build/select models is inherently flawed, and in my experience, I consistenly find major flaws in the "logic" of my own analyses, let alone someone elses. So, if we are doing this to make (cue scary music) "the agency" happy, should we first ask if they care? (actually I have, but I'll let them speak for themselves). But, as pretty much everyone else I suspect, I make a table of every "relevant" model, with comments, why it was accepted (as current best), or not, and include control files for all "relevant" models in an appendix. Except of course for GA, when I have 6000-10000 models, then I just give a description of the search space and the final model - much shorter report, and can absolutely, alway reproduce the logic - and it is actually logical. So, I'm personally happy to see that the CHMP guidelines don't require the regurgitation of what is probably alway illogical "logic", but focus on the value of the final result. Mark Sale MD Next Level Solutions, LLC www.NextLevelSolns.com