Loky do ★ Egypt, 2020-08-09 13:50 (1648 d 22:22 ago) Posting: # 21842 Views: 3,772 |
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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 |
Helmut ★★★ ![]() ![]() Vienna, Austria, 2020-08-09 14:08 (1648 d 22:05 ago) @ Loky do Posting: # 21843 Views: 2,982 |
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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. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![]() Helmut Schütz ![]() The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Loky do ★ Egypt, 2020-08-09 21:06 (1648 d 15:07 ago) @ Helmut Posting: # 21845 Views: 2,956 |
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Thanks, Helmut your response always very helpful for us ![]() |
wienui ★ Germany/Oman, 2020-08-10 10:00 (1648 d 02:13 ago) @ Loky do Posting: # 21847 Views: 2,901 |
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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 |