Bioequivalence and Bioavailability Forum • Dosing of oral sprinkle granules

Loky do
★

Egypt,
2025-12-04 19:54
(187 d 13:02 ago)

Posting: # 24520
Views: 1,775

Dosing 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In a bioequivalence study of deferasirox oral sprinkle granules, the FDA draft guidance recommends conducting both fasted and fed studies.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

jag009 ★★★ NJ, 2026-01-21 19:24 (139 d 13:32 ago) @ Loky do Posting: # 24552 Views: 1,087	Dosing of oral sprinkle granules Post reply
	❝ In a bioequivalence study of deferasirox oral sprinkle granules, the FDA draft guidance recommends […] This one? Deferasirox J

Darborn ☆ Taiwan, 2026-01-22 09:52 (138 d 23:04 ago) @ Loky do Posting: # 24553 Views: 1,065	Dosing of oral sprinkle granules Post reply
	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.