multiple dose bio­equi­va­lence study [Design Issues]

posted by wienui  – Germany, Oman, 2020-08-10 08:00 (44 d 03:02 ago) – Posting: # 21847
Views: 855

(edited by wienui on 2020-08-10 08:19)

Hi Loky do & Helmut,

» 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.

Cheers,
Osama

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