internal tools and modelling [R for BE/BA]

posted by mittyri – Russia, 2020-01-28 16:00 (674 d 09:45 ago) – Posting: # 21091
Views: 2,852

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
21,785 posts in 4,556 threads, 1,547 registered users;
online 3 (1 registered, 2 guests [including 2 identified bots]).
Forum time: Friday 01:46 CET (Europe/Vienna)

A drug is that substance which, when injected into a rat,
will produce a scientific report.    Anonymous

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