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Registermultiple dose bioequivalence study [Design Issues]
Hi Loky do & Helmut,
Yes, you need an MD (SS) study as Helmut mentioned above. Please note that the GCC GL was adopted originally from the EMA GL, therefore it follows it, although some points could be not clear included.
❝ 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.
Yes, you need an MD (SS) study as Helmut mentioned above. Please note that the GCC GL was adopted originally from the EMA GL, therefore it follows it, although some points could be not clear included.
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Cheers,
Osama
Cheers,
Osama
Complete thread:
- multiple dose bioequivalence study Loky do 2020-08-09 11:50 [Design Issues]
![[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 studywienui 2020-08-10 08:00
- EMA MR: long half life → MD Helmut 2020-08-09 12:08
Ing. Helmut Schütz