I know Winnonlin is required by FDA for individual pk study in industry.
What about population pk? is there any requirement of which software should
be used to conduct the study?
I just browsed the FDA guidance for population pharmacokinetics and didn't
find any information regarding this. it only states "It is crucial that the
software used for population analysis be adequately supported and maintained
."
Does it mean software other than NONMEM can be used, like Monolix? I don’t
want to publis
