internal tools and modelling [R for BE/BA]

posted by mittyri – Russia, 2020-01-28 16:00 (309 d 22:14 ago) – Posting: # 21091
Views: 1,882

Hi Achievwin,

» 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)

Kind regards,
Mittyri

Complete thread:

Activity
 Admin contact
21,234 posts in 4,428 threads, 1,484 registered users;
online 5 (1 registered, 4 guests [including 2 identified bots]).
Forum time: Thursday 14:15 CET (Europe/Vienna)

Every man is fully satisfied that there is such a thing as truth,
or he would not ask any question.    Charles Sanders Peirce

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5