multiple dose bioequivalence study [Design Issues]

posted by Loky do – Egypt, 2020-08-09 13:50 (1789 d 02:52 ago) – Posting: # 21842
Views: 4,138

Dears

If we have solifenacin 6 mg (immediate-release) / tamsulosin 0.4 mg modified-release product combination, is multiple-dose bioequivalence study required to be submitted to the European authorities in addition to fast & fed studies, as there is no specific guidance for this product & in GCC region fast & fed studies only accepted.

Thanks in advance

Complete thread:

UA Flag
Activity
 Admin contact
23,426 posts in 4,929 threads, 1,682 registered users;
32 visitors (0 registered, 32 guests [including 10 identified bots]).
Forum time: 16:43 CEST (Europe/Vienna)

You can do one of two things; just shut up,
which is something I don’t find easy,
or learn an awful lot very fast,
which is what I tried to do.    Jane Fonda

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