multiple dose studies [Design Issues]
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]
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:
- multiple dose studiesLoky do 2024-03-04 10:27 [Design Issues]
- multiple dose studies dshah 2024-03-08 17:36
- multiple dose studies Loky do 2024-03-11 11:20
- multiple dose studies dshah 2024-03-12 17:37
- multiple dose studies Loky do 2024-03-11 11:20
- multiple dose studies dshah 2024-03-08 17:36