multiple dose studies [Design Issues]

posted by Loky do – Egypt, 2024-03-04 11:27 (493 d 02:40 ago) – Posting: # 23892
Views: 4,273

Dears

I have a solifenacin succinate/tamsulosin HCl bioequivalence study, I will perform a multiple-dose study for tamsulosin modified release for Europe, I'm a little confused about the planned washout for this study as there are no enough public assessment reports for the combination, should I take in account the solifenacin washout period also or to design on tamsulosin only is enough (i.e one-week washout between 2 periods from last dose)

thanks in advance


Edit: Category changed; see also this post #1[Helmut]

Complete thread:

UA Flag
Activity
 Admin contact
23,428 posts in 4,929 threads, 1,682 registered users;
54 visitors (1 registered, 53 guests [including 12 identified bots]).
Forum time: 15:08 CEST (Europe/Vienna)

To know that we know what we know,
and to know that we do not know what we do not know,
that is true knowledge.    Nicolaus Copernicus

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