sprinkle study [Design Issues]

posted by velupharm – 2006-07-21 14:34 (6095 d 13:44 ago) – Posting: # 181
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we plan to do a sprinkle study on fed state for a extended release preparation as per USFDA requirements. but the innovators prescribing information just gives a line that it is bioequivalent with the routine single dose fed study. are there any studies with any molecule that mentions the exact levels like Cmax, AUC of both sprikle and fed studies? or are there any articles that gives the actual relationship between these two studies?

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