Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Back to the forum  2018-06-22 07:45 CEST (UTC+2h)

How to waive bridging studies by statistical calculations? [Regulatives / Guidelines]

posted by DavidManteigas - Portugal, 2017-10-12 19:04  - Posting: # 17893
Views: 1,067

I am not Mr Schütz, but I can't see any statistical calculations that will prevent you from doing a study in Turkey since that seems the opinion of the regulator regardless of any statistics.

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,413 posts in 3,912 threads, 1,175 registered users;
online 42 (0 registered, 42 guests [including 32 identified bots]).

The greatest shortcoming of the human race is our inability
to understand the exponential function.    Albert Bartlett

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