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RegisterDosing of oral sprinkle granules [Design Issues]
Hi Loky do
In my opinion, a BE study is intended to demonstrate therapeutic equivalence under the SAME connitions as required by the RLD label. If you conduct a BE study with the administration method differing from the RLD label, it seems meaningless. Thus, both fasted and fed conditions should use the sprinkle procedure mentioned in the label.
In my opinion, a BE study is intended to demonstrate therapeutic equivalence under the SAME connitions as required by the RLD label. If you conduct a BE study with the administration method differing from the RLD label, it seems meaningless. Thus, both fasted and fed conditions should use the sprinkle procedure mentioned in the label.
Complete thread:
- Dosing of oral sprinkle granules Loky do 2025-12-04 18:54
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Dosing of oral sprinkle granules jag009 2026-01-21 18:24
- Dosing of oral sprinkle granulesDarborn 2026-01-22 08:52
Ing. Helmut Schütz