EMA MR: long half life → MD [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2020-08-09 12:08 (690 d 00:23 ago) – Posting: # 21843
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Hi Loky do,

» […] 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,

Yes, since due to their long half lives waiving of the multiple dose study will not be possible (see this post). Given the half life of tamsulosin the MD study will be nasty.

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