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Registermultiple dose bioequivalence study [Design Issues]
Dears
If we have solifenacin 6 mg (immediate-release) / tamsulosin 0.4 mg modified-release product combination, is multiple-dose bioequivalence study required to be submitted to the European authorities in addition to fast & fed studies, as there is no specific guidance for this product & in GCC region fast & fed studies only accepted.
Thanks in advance
If we have solifenacin 6 mg (immediate-release) / tamsulosin 0.4 mg modified-release product combination, is multiple-dose bioequivalence study required to be submitted to the European authorities in addition to fast & fed studies, as there is no specific guidance for this product & in GCC region fast & fed studies only accepted.
Thanks in advance
Complete thread:
- multiple dose bioequivalence studyLoky do 2020-08-09 11:50
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- EMA MR: long half life → MD Helmut 2020-08-09 12:08
- EMA MR: long half life → MD Loky do 2020-08-09 19:06
- multiple dose bioequivalence study wienui 2020-08-10 08:00
- EMA MR: long half life → MD Helmut 2020-08-09 12:08
Ing. Helmut Schütz