Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-08-17 09:45 CEST (UTC+2h)
 

Fed VS Fast state in BE studies [Design Issues]

posted by M.tareq - 2017-02-26 09:34  - Posting: # 17110
Views: 1,471

Dear all ,.
question about fed state design and fast one in a modified release drug

due to expected high variability in fed state study we will use partial replicate design,
however there's no expected high variability in fast state (PPI drug)
my question is the design for the fed state should be the same for fast one ? i.e partial replicate ? and the basis for that if yes, mean we are comparing the test in fed state vs ref in fed state and vice versa

N.B according to EMA guidelines

Thanks in advance

best regards

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum | Admin contact
17,199 Posts in 3,683 Threads, 1,054 registered users;
31 users online (1 registered, 30 guests).

To call the statistician after the experiment is done
may be no more than asking him to perform a postmortem examination:
he may be able to say what the experiment died of.    R.A. Fisher

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
XHTML/CSS RSS Feed