High CV? [Design Issues]

posted by d_labes  – Berlin, Germany, 2016-05-03 21:07 (2091 d 08:48 ago) – Posting: # 16276
Views: 6,792

Dear Helmut,

» Adding to Detlew’s wise words: For a CVwR of 54% I would expect no inflation of the TIE with the FDA’s RSABE and practically none with the EMA’s ABEL.

where did this CVwR you mention came from? I couldn't detect such a number in this thread. Did you use a crystal ball [image] to figure it out in M.tareq's post? Or do you have some insider information?



Complete thread:

 Admin contact
21,844 posts in 4,571 threads, 1,555 registered users;
online 2 (0 registered, 2 guests [including 2 identified bots]).
Forum time: Monday 04:56 CET (Europe/Vienna)

Do, or do not.
There is no ‘try’.    Yoda

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