Bioequivalence and Bioavailability Forum

multiple dose studies [Design Issues]

posted by dshah  – India, 2024-03-12 18:37 (485 d 13:22 ago) – Posting: # 23905
Views: 3,187

Hello Loky do!

❝ I'm a little confused why to analyze solifenacin as it is immediate release and the concern towards tamsulosin as it is the delayed release one, even if I took into consideration the washout of both, are the results of solifenacin, in this case, affect those of tamsulosin?

❝

Kindly refer section 3 of EMA guideline on FDC.


Considering as a sponsor, the analysis of solifenacin adds a cost. But as a regulator- if you are taking the sample- why it is not analyzed? Any SE relation with PK would not be feasible, then.

Regards,
Divyen

Complete thread:

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