Fast & fed studies [Design Issues]

posted by alghazam – Jordan, 2020-03-03 11:24 (1487 d 00:22 ago) – Posting: # 21193
Views: 3,081

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:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
87 visitors (0 registered, 87 guests [including 8 identified bots]).
Forum time: 11:47 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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