multiple dose studies [Design Issues]

posted by Loky do – Egypt, 2024-03-04 11:27 (46 d 23:12 ago) – Posting: # 23892
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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]

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