Re: NONMEM in drug development

From n.holford@auckland.ac.nz Thu Jul 4 22:39:55 1996 Subject: Re: NONMEM in drug development Rik, I think that trying to convince the `top' consultant by attempting to prove that NONMEM was `necessary/essential' is a priori a waste of time. Suppose you were asked to prove that SAS was `necessary/essential' could you do it? I doubt it. NONMEM and SAS are tools which are used to support the approval process. Only a fool would expect approval to be conditional on the `necessity' of using a particular tool. A series of NONMEM based analyses were used separately and as a meta-analysis to support the approval of tacrine. The advisory committee did not state officially to what extent, if any, these analyses were pivotal. The refs can be found in Holford NHG, Peace K. The effect of tacrine and lecithin in Alzheimer's disease. A population pharmacodynamic analysis of five clinical trials. Europ. J. Clin. Pharmacol. 1994; 47:17-24. -- 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