multiple dose bioequivalence study [Design Issues]

posted by Loky do – Egypt, 2020-08-09 11:50 (159 d 05:47 ago) – Posting: # 21842
Views: 1,397

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:

Activity
 Admin contact
21,303 posts in 4,441 threads, 1,488 registered users;
online 5 (0 registered, 5 guests [including 5 identified bots]).
Forum time: Friday 16:37 CET (Europe/Vienna)

Statistics is the grammar of science.    Karl Pearson

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