Bioequivalence and Bioavailability Forum • multiple dose studies

multiple dose studies [Design Issues]

posted by dshah – India, 2024-03-08 18:36 (429 d 20:18 ago) – Posting: # 23895
Views: 2,808

Hello Loky do!

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❝ 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)

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As this is FDC- both the drug needs to be analyzed and thus also consider Solifenacin for washout consideration.

Regards,
Divyen

Complete thread:

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