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RegisterDosing of oral sprinkle granules [Design Issues]
Dears
In a bioequivalence study of deferasirox oral sprinkle granules, the FDA draft guidance recommends conducting both fasted and fed studies. However, the FDA label states that the dose should be administered by sprinkling the granules onto a soft food such as yogurt or applesauce. For the fasted BE study, should the dose still be administered by sprinkling the granules onto a soft food (e.g., yogurt or applesauce), or should it be given differently to comply with fasting conditions?
Thanks in advance
In a bioequivalence study of deferasirox oral sprinkle granules, the FDA draft guidance recommends conducting both fasted and fed studies. However, the FDA label states that the dose should be administered by sprinkling the granules onto a soft food such as yogurt or applesauce. For the fasted BE study, should the dose still be administered by sprinkling the granules onto a soft food (e.g., yogurt or applesauce), or should it be given differently to comply with fasting conditions?
Thanks in advance
Complete thread:
- Dosing of oral sprinkle granulesLoky do 2025-12-04 18:54 [Design Issues]
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- Dosing of oral sprinkle granules jag009 2026-01-21 18:24
- Dosing of oral sprinkle granules Darborn 2026-01-22 08:52
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