Re: NONMEM in drug development -Reply

From n.holford@auckland.ac.nz Thu Jul 11 17:19:45 1996 Subject: Re: NONMEM in drug development -Reply I was at this workshop too. I dont exactly recall all the weasel words ("good population", "pivotal", "dose-titration") you cite above but I know of and Bob Temple knows of (he was on the Advisory Committee) at least one drug that was approved by the FDA in which the "pivotal" trials were supported by a NONMEM analysis which explicitly defined the dose-response relationship (that had eluded traditional methods). The design of the studies had an explicit "dose-titration" phase. The drug was tacrine. I have no idea what a "good population" might be! I have previously posted to this thread a citation to the supporting NONMEM analysis. -- Nick Holford, Dept Pharmacology & Clinical Pharmacology University of Auckland, Private Bag 92019, Auckland, New Zealand email:n.holford@auckland.ac.nz tel:+64(9)373-7599x6730 fax:373-7556 http://www.phm.auckland.ac.nz/Staff/NHolford/nholford.html