Which country? [Two-Stage / GS Designs]

posted by Elena777 – Belarus, 2019-09-11 22:24 (1883 d 11:26 ago) – Posting: # 20587
Views: 12,816

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:

UA Flag
Activity
 Admin contact
23,288 posts in 4,890 threads, 1,660 registered users;
72 visitors (0 registered, 72 guests [including 9 identified bots]).
Forum time: 08:50 CET (Europe/Vienna)

There are no dangerous thoughts;
thinking itself is dangerous.    Hannah Arendt

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