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RegisterDifferent strenghts [Design Issues]
posted by Helmut 
– Vienna, Austria, 2014-12-22 03:58 (4199 d 13:41 ago) – Posting: # 14133
Views: 5,858
Hi cher0424
No. The hybrid pathway in the EU means PK + some clinical stuff in patients (therapeutic equivalence or non-inferiority). In my case I had one comparative BA-study (that’s not BE!) and two TE studies. And yes: In both TE studies dose tritration.
❝ ❝ • 20 mg new MR vs. 2 × 10 mg IR, hybrid pathway (two clinical studies; individualized doses up to 60 mg). ⇒ Approval of 20 mg.
❝
❝ Can you specify what are these two clinical studies? One BE, and one dose up study?
No. The hybrid pathway in the EU means PK + some clinical stuff in patients (therapeutic equivalence or non-inferiority). In my case I had one comparative BA-study (that’s not BE!) and two TE studies. And yes: In both TE studies dose tritration.
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
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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
Complete thread:
- Different strenghts prashantmohite 2014-12-20 04:57
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Different strenghts ElMaestro 2014-12-20 13:19
- Different strenghts Helmut 2014-12-20 14:24
- Different strenghts cher0424 2014-12-22 02:30
- Different strenghtsHelmut 2014-12-22 02:58
- Different strenghts mittyri 2014-12-22 20:30
- Different strenghtsHelmut 2014-12-22 02:58
- Different strenghts cher0424 2014-12-22 02:30
- Different strenghts Helmut 2014-12-20 14:24
- Different strenghts ElMaestro 2014-12-20 13:19
Ing. Helmut Schütz