EMA: Cmin [Regulatives / Guidelines]

posted by Priyanka_S – 2010-03-09 11:46 (5955 d 15:57 ago) – Posting: # 4883
Views: 2,928

Dear all,

The recent Europe guidelines, for steady state studies the parameter Cmin is excluded from Bioequivalence criteria for Immediate relese formulations.

But we want to conduct a steady state study (for Europe) for modified release formulation. Please suggest me the parameter Cmin should require for bioequivalence criteria?
—
Best Regards

Priyanka S

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
368 visitors (0 registered, 368 guests [including 26 identified bots]).
Forum time: 04:44 CEST (Europe/Vienna)

Most scientists today are devoid of ideas, full of fear, intent on
producing some paltry result so that they can add to the flood
of inane papers that now constitutes “scientific progress”
in many areas.    Paul Feyerabend

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