Failure of BE in fasting studies [Study As­sess­ment]

posted by drgunasakaran1  – 2012-10-10 21:14 (5003 d 15:14 ago) – Posting: # 9380
Views: 12,298

Dear Dr Chirag,
I fully agree with answers of Dr_Dan and Mr Helmut. Regulatory will accept two different study designs for fasted and fed conditions.

Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,571 registered users;
114 visitors (0 registered, 114 guests [including 12 identified bots]).
Forum time: 12:29 CEST (Europe/Vienna)

Competence, like truth, beauty and contact lenses,
is in the eye of the beholder.    Laurence J. Peter

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