Re: NONMEM in drug development

From JEAN-LOUIS.STEIMER@roche.com Fri Jul 5 00:05:13 1996 Subject: Re: NONMEM in drug development A useful (but older) reference is the Chapter ( I sell my stuff...) Steimer JL, Vozeh S, Racine-Poon A, Holford N, O=92Neill R (1994) The population approach: rationale, methods, and applications in clinical pharmacology and drug development. In: Welling PE, Balant LP (eds) Handbook of Experimental Pharmacology, Vol. 110 Pharmacokinetics of Drugs. Springer-Verlag Berlin Heidelberg There is a table there specifically listing the applications of the population approach in drug development, which contains 13 references between 1982 and 1992, mostly associated with NONMEM analysis. Of course, it needs updating... But the tricky statement is Rick's mail is "where use of NONMEM had been necessary/essential...". Who can judge that? How "essential" to an approval has a t-test or any piece of software ever been? I guess it's the data that matters... At best, a statistical methodology can be rated as being useful. And that's precisely what NONMEM is. Well: An input from our colleagues in regulatory bodies may be helpful...=20 I do think that there is a balance to be found between the "overrating" and the "underrating". Rather than wasting time in discussing with "top-consultants to the pharnmaceutical industry" who underrate the methodology, let's indeed, as Rik suggests, just refer them to the literature and to current practice. More and more examples are coming, as many recent international meetings show... One approach may be to go through the publications's list that the NONMEM PRoject Group is maintaining, and to tick those papers that refer to compounds in development....Is anyone volunteering for updating the list=20 started in the chapter in that way? Jean-Louis Steimer