NONMEM in drug development

From Janet.Wade@lv.mpa.400net.tip.net Tue Jul 9 01:10:16 1996 Subject: NONMEM in drug development Hi Rik As a regulatory person I find it quite depressing that a `top' consultant could still be posing such a silly challenge as to the usefulness of NONMEM (or any other piece of population software) in drug development. The answers given by Nick, Jean-Louis and Pascal have, I hope, given you sufficient evidence to beat your consultant around the head with. I firmly believe that a population approach, properly applied and reported, gives those of us in the regulatory business a much better understanding of the mechanisms that govern the pharmacokinetics and pharmacodynamics of a new drug. I also believe (even more strongly if that is possible!) that it is a highly underused approach when it comes to characterising dose response relationships. I am actively encouraging companies that come to visit us here at the MPA in Sweden to consider using the approach to better characterise dose reponse relationships. I would like to add something further to Rik's second e-mail summarising the discussion so far. With respect to my recent presentation at PAGE 96, I have not only seen protocols in which population analyses were included but there has also been a number of reports of population analyses submitted to the agency. Some of these have been crucial in characterising covariate effects (or lack of) since traditional trials were unavailable. There has also been one instance where the population analysis provided the only believable evidence for a dose reponse relationship. Janet R. Wade