internal tools and modelling [🇷 for BE/BA]
Hi Achievwin,
really interesting how do they come with modelling where NONMEM is attacked by many competitors (R: nlmixr or solutions with common ODE solvers; RStan)
❝ The short and sweet answer was you can submit your analysis whatever the software you are comfortable FDA runs their own analysis using internal tools, in the event the results differs 9by what magnitude is subjective) it triggers a review question.
really interesting how do they come with modelling where NONMEM is attacked by many competitors (R: nlmixr or solutions with common ODE solvers; RStan)
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Kind regards,
Mittyri
Kind regards,
Mittyri
Complete thread:
- R in regulated environments Helmut 2019-08-28 14:58
- FDA, again Helmut 2020-01-09 16:04
- R in regulated environments Achievwin 2020-01-27 20:21
- R in regulated environments ElMaestro 2020-01-27 23:13
- internal tools and modellingmittyri 2020-01-28 16:00