Fast & fed studies [Design Issues]

posted by alghazam – Jordan, 2020-03-03 10:24 (209 d 07:16 ago) – Posting: # 21193
Views: 1,879

Dear Amira,
It is clearly stated in EMA guidance of 2010 on page 10/27 (lines 6-7) that "In cases where information is required in both the fed and fasted states, it is acceptable to conduct either two separate two-way cross-over studies or a four-way cross-over study."
hope this helps.
Mutasim

Complete thread:

Activity
 Admin contact
21,084 posts in 4,398 threads, 1,468 registered users;
online 5 (1 registered, 4 guests [including 2 identified bots]).
Forum time: Monday 18:41 CEST (Europe/Vienna)

A central lesson of science is that to understand complex issues
(or even simple ones), we must try to free our minds of dogma and
to guarantee the freedom to publish, to contradict, and to experiment.
Arguments from authority are unacceptable.    Carl Sagan

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