Which country? [Two-Stage / GS Designs]

posted by Elena777 – Belarus, 2019-09-11 20:24  – Posting: # 20587
Views: 1,814

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
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,987 posts in 4,229 threads, 1,374 registered users;
online 17 (0 registered, 17 guests [including 6 identified bots]).
Forum time (Europe/Vienna): 19:44 CET

To know the history of science is to recognize the mortality
of any claim to universal truth.    Evelyn Fox Keller

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5