EMA MR: long half life → MD [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2020-08-09 12:08 (433 d 11:05 ago) – Posting: # 21843
Views: 1,415

Hi Loky do,

» […] 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,

Yes, since due to their long half lives waiving of the multiple dose study will not be possible (see this post). Given the half life of tamsulosin the MD study will be nasty.

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Activity
 Admin contact
21,729 posts in 4,543 threads, 1,543 registered users;
online 5 (0 registered, 5 guests [including 3 identified bots]).
Forum time: Saturday 23:13 CEST (Europe/Vienna)

If you want to converse with me,
define your terms.    Voltaire

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