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RegisterFed VS Fast state in BE studies [Design Issues]
Dear all ,.
question about fed state design and fast one in a modified release drug
due to expected high variability in fed state study we will use partial replicate design,
however there's no expected high variability in fast state (PPI drug)
my question is the design for the fed state should be the same for fast one ? i.e partial replicate ? and the basis for that if yes, mean we are comparing the test in fed state vs ref in fed state and vice versa
N.B according to EMA guidelines
Thanks in advance
best regards
question about fed state design and fast one in a modified release drug
due to expected high variability in fed state study we will use partial replicate design,
however there's no expected high variability in fast state (PPI drug)
my question is the design for the fed state should be the same for fast one ? i.e partial replicate ? and the basis for that if yes, mean we are comparing the test in fed state vs ref in fed state and vice versa
N.B according to EMA guidelines
Thanks in advance
best regards
Complete thread:
- Fed VS Fast state in BE studiesM.tareq 2017-02-26 09:34 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Fed VS Fast state in BE studies Dr_Dan 2017-02-27 11:01
- PPIs sometimes highly variable even in fasted state Helmut 2017-02-27 11:32
- PPIs sometimes highly variable even in fasted state DavidManteigas 2017-02-27 16:08
- Refuse-to-Receive Standards Helmut 2017-02-27 16:25
- Refuse-to-Receive Standards M.tareq 2017-03-17 13:11
- Refuse-to-Receive Standards nobody 2017-03-17 16:27
- Refuse-to-Receive Standards Helmut 2017-02-27 16:25
- PPIs sometimes highly variable even in fasted state DavidManteigas 2017-02-27 16:08
- PPIs sometimes highly variable even in fasted state Helmut 2017-02-27 11:32
- Fed VS Fast state in BE studies Dr_Dan 2017-02-27 11:01
Ing. Helmut Schütz