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Register4x4-fasting-fed study [Design Issues]
Dear Dr_Dan,
Thanks for sharing the 'common-sense' approach. I would also plan 2 seperate studies. This plan would be perfect for EU submission.
However, FDA requires studies for both fasting and fed and if literature dosent say much interference with meal conditions and invitro equivalence is confirmed, Beman approach appears appealing
Kind regards,
Tina
Thanks for sharing the 'common-sense' approach. I would also plan 2 seperate studies. This plan would be perfect for EU submission.
However, FDA requires studies for both fasting and fed and if literature dosent say much interference with meal conditions and invitro equivalence is confirmed, Beman approach appears appealing
Kind regards,
Tina
Complete thread:
- 4x4-fasting-fed study beman 2014-04-04 13:48
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 4x4-fasting-fed study Helmut 2014-04-04 14:00
- Two stage design in a 4 way crossover fasting-fed BE study Tina 2014-05-16 10:35
- TSD: 2 cross-overs Helmut 2014-05-16 12:03
- Two stage design in a 4 way crossover fasting-fed BE study Tina 2014-05-16 10:35
- 4x4-fasting-fed study Dr_Dan 2014-04-04 19:44
- 4x4-fasting-fed studyTina 2014-05-16 12:31
- 4x4-fasting-fed study Helmut 2014-04-04 14:00
Ing. Helmut Schütz