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RegisterEMA MR: long half life → MD [Design Issues]
posted by Helmut 
– Vienna, Austria, 2020-08-09 12:08 (113 d 00:40 ago) – Posting: # 21843
Views: 1,014
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.
» […] 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 🖖
Helmut Schütz
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Dif-tor heh smusma 🖖
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- multiple dose bioequivalence study Loky do 2020-08-09 11:50 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- EMA MR: long half life → MDHelmut 2020-08-09 12:08
- EMA MR: long half life → MD Loky do 2020-08-09 19:06
- multiple dose bioequivalence study wienui 2020-08-10 08:00
- EMA MR: long half life → MDHelmut 2020-08-09 12:08
Ing. Helmut Schütz