Loky do
★    

Egypt,
2020-08-09 13:50
(2142 d 13:31 ago)

Posting: # 21842
Views: 5,533
 

 multiple dose bioequivalence study [Design Issues]

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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
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Vienna, Austria,
2020-08-09 14:08
(2142 d 13:13 ago)

@ Loky do
Posting: # 21843
Views: 4,406
 

 EMA MR: long half life → MD

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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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Loky do
★    

Egypt,
2020-08-09 21:06
(2142 d 06:16 ago)

@ Helmut
Posting: # 21845
Views: 4,409
 

 EMA MR: long half life → MD

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Thanks, Helmut your response always very helpful for us ;-)
 
wienui
★    

Germany/Oman,
2020-08-10 10:00
(2141 d 17:22 ago)

@ Loky do
Posting: # 21847
Views: 4,325
 

 multiple dose bio­equi­va­lence study

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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.
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