deepmala gupta
●    

2011-12-08 08:32
(5314 d 22:01 ago)

Posting: # 7765
Views: 3,045
 

 Ursodiol Standard breakfast on -48, -24 hours, dosing day [Design Issues]

Post reply
Dear All Freinds

I had an query for the Bioequivalence study of ursodiol, that its BE recomendation says that standard breakfast will be given at -48 hours, -24 hours and 30 minutes prior to dosing,
I just wanted to know what should be the standard breakfast for fed study.


Regards
Deepmala Gupta
Clinical Research Associate

Edit: Ref. to FDA’s draft guidances: Tablets (08/2008), Capsules (02/20110). [Helmut]
 
UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
373 visitors (0 registered, 373 guests [including 18 identified bots]).
Forum time: 07:33 CEST (Europe/Vienna)

Don’t compromise yourself.
You are all you’ve got.    Janis Joplin

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