multiple dose bioequivalence study [Design Issues]

posted by Loky do – Egypt, 2020-08-09 13:50 (1443 d 15:43 ago) – Posting: # 21842
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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

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