multiple dose studies [Design Issues]

posted by dshah  – India/United Kingdom, 2024-03-12 18:37 (69 d 10:44 ago) – Posting: # 23905
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Hello Loky do!

❝ I'm a little confused :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.
[image]

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

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