arunkumar
●    

2009-06-03 15:41
(6233 d 23:05 ago)

Posting: # 3812
Views: 5,372
 

 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
(6232 d 23:43 ago)

@ arunkumar
Posting: # 3822
Views: 4,076
 

 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, 1,572 registered users;
320 visitors (0 registered, 320 guests [including 11 identified bots]).
Forum time: 14:46 CEST (Europe/Vienna)

The real struggle is not between the right and the left
but between the party of the thoughtful
and the party of the jerks.    Jimmy Wales

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