Which country? [Two-Stage / GS Designs]

posted by Elena777 – Belarus, 2019-09-11 20:24 (686 d 02:18 ago) – Posting: # 20587
Views: 6,086

Dear Helmut and ElMaestro,

Thank you very much for responding me shortly. We are planning to submit applications in Belarus (the country I`m from) and in Russia. Hope method C will be OK for them.

Another 2 questions:
  1. Is it a good idea to add the statement that, in case of conducting stage 2, data from both stages will be pooled by default, without evaluation of differences between stages?
  2. Is there any established minimum for a number of subjects that should be included in stage 2 (e.g. at least 2, or at least 1 for each sequence (TR/RT))?

Complete thread:

Activity
 Admin contact
21,590 posts in 4,513 threads, 1,531 registered users;
online 10 (0 registered, 10 guests [including 3 identified bots]).
Forum time: Wednesday 22:42 CEST (Europe/Vienna)

If a man will begin with certainties, he will end in doubts;
but if he will be content to begin with doubts,
he will end in certainties.    Francis Bacon

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