Log in
RegisterPPIs sometimes highly variable even in fasted state [Design Issues]
Dear all,
Sometimes FDA ask for both fed and fast studies for products for which the SmPC states that no interaction with food occur. In those cases, would it be acceptable to use different designs for each study? Even when the variability in the fed study was preivously found to be higher in pilot studies, for example?
Never happened to me. I'm asking just for curiosity, since from my experience fed studies generally have higher variability than fast studies even when no food effect is expected.
Regards
Sometimes FDA ask for both fed and fast studies for products for which the SmPC states that no interaction with food occur. In those cases, would it be acceptable to use different designs for each study? Even when the variability in the fed study was preivously found to be higher in pilot studies, for example?
Never happened to me. I'm asking just for curiosity, since from my experience fed studies generally have higher variability than fast studies even when no food effect is expected.
Regards
Complete thread:
- Fed VS Fast state in BE studies M.tareq 2017-02-26 09:34
![[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 stateDavidManteigas 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 stateDavidManteigas 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