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RegisterDose for BE study [Design Issues]
Dear Mayur661
Honestly, if you know, that there is such a significant food effect on only the reference formulation that you need twice the dose compared to test, how can you think to reach bioequivalence in the fed state? You have a different formulation with a different PK characteristic and different food effect. No chance, you have to reformulate!
Kind regards
Dan
Honestly, if you know, that there is such a significant food effect on only the reference formulation that you need twice the dose compared to test, how can you think to reach bioequivalence in the fed state? You have a different formulation with a different PK characteristic and different food effect. No chance, you have to reformulate!
Kind regards
Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Dose for BE study mayur661 2010-06-02 14:57
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Dose for BE study Dr_Dan 2010-06-02 15:11
- Dose for BE study mayur661 2010-06-03 14:28
- Last warning Helmut 2010-06-03 14:38
- Dose for BE studyDr_Dan 2010-06-03 15:06
- Dose for BE study mayur661 2010-06-03 14:28
- Dose for BE study Dr_Dan 2010-06-02 15:11
Ing. Helmut Schütz