steady state for modified release [Regulatives / Guidelines]

posted by Kelen – Brazil, 2019-09-20 18:04 (485 d 03:02 ago) – Posting: # 20636
Views: 3,555

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:

Activity
 Admin contact
21,303 posts in 4,441 threads, 1,487 registered users;
online 4 (0 registered, 4 guests [including 3 identified bots]).
Forum time: Sunday 21:07 UTC (Europe/Vienna)

No problem can stand the assault of sustained thinking.    Voltaire

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