Bioequivalence and Bioavailability Forum • multiple dose studies

multiple dose studies [Design Issues]

posted by dshah – India, 2024-03-08 18:36 (490 d 17:05 ago) – Posting: # 23895
Views: 3,282

Hello Loky do!

❝

❝ 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)

❝

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