arunkumar
●    

2009-06-03 15:41
(6229 d 12:22 ago)

Posting: # 3812
Views: 5,353
 

 azacitidine BE study [Design Issues]

Post reply
can somebody contribute on the design of azacitidine BE study in patients with MDS (myelodysplatic syndrome)?
generally is it done as two period cross over study or as the evaluation of steady state PK?
also any tips for the BA method of azacitidine such as equipment, range, etc..?
 
hariemmadi
●    

2009-06-04 15:03
(6228 d 13:00 ago)

@ arunkumar
Posting: # 3822
Views: 4,063
 

 azacitidine BE study

Post reply
Dear arunkumar,

i hope you may get some idea about the design if you refer azacitidine draft individual product bioequivalence recommendation on USFDA site.

Edit: Full quote removed. @Hari: Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
PS.: FDA's draft guideline.
 
UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,571 registered users;
140 visitors (1 registered, 139 guests [including 37 identified bots]).
Forum time: 04:03 CEST (Europe/Vienna)

Scientists often have a naïve faith that
if only they could discover enough facts about a problem,
these facts would somehow arrange themselves
in a compelling and true solution.    Theodosius Dobzhansky

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