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RegisterOnly fed study [Design Issues]
With reference to ANDA submission for US FDA, If the prescribing information says that the drug has to be taken under fed condition then whether it is necessary to conduct both fasted and fed studies? Can we only submit the fed study for immediate release formulation?
Complete thread:
- Only fed studyroody 2005-10-04 19:10 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Only fed study Helmut 2005-10-04 19:45
- Only fed study Jaime_R 2005-10-04 20:42
- Only fed study Helmut 2005-10-04 19:45
Ing. Helmut Schütz