should sprinkle BE study be in fasting condition only or also in fed? [Regulatives / Guidelines]

posted by jag009  – NJ, 2016-05-10 01:14 (3200 d 06:17 ago) – Posting: # 16286
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Hi,

❝ Does that mean if RLD can be administered sprinkled with applesauce, the ANDA product should conduct an additional fasting sprinkle-in-applesauce BE study?


At least in most (if not all guidances) I have read.

John

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