internal tools and modelling [🇷 for BE/BA]

posted by mittyri – Russia, 2020-01-28 17:00 (1484 d 09:16 ago) – Posting: # 21091
Views: 4,047

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:

UA Flag
Activity
 Admin contact
22,899 posts in 4,806 threads, 1,651 registered users;
22 visitors (0 registered, 22 guests [including 7 identified bots]).
Forum time: 02:17 CET (Europe/Vienna)

Statistics is, or should be, about scientific investigation
and how to do it better, but many statisticians believe
it is a branch of mathematics.    George E.P. Box

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