deepmala gupta
●    

2011-12-08 08:32
(5311 d 14:51 ago)

Posting: # 7765
Views: 3,032
 

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

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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]
 
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