steady state for modified release [Regulatives / Guidelines]

posted by Kelen – Brazil, 2019-09-20 20:04  – Posting: # 20636
Views: 1,119

I would like to ask help for understand the objetive of the steady state study when you are comparing a MR formulation with a IR formulation. The objective would be compare the effect of the accumulation? Is there any reason to conduct the study only with de highest dose?

Edit: Please follow the Forum’s Policy[Helmut]

Complete thread:

 Admin contact
20,249 posts in 4,261 threads, 1,397 registered users;
online 10 (0 registered, 10 guests [including 5 identified bots]).
Forum time (Europe/Vienna): 18:38 CET

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 and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz