BE study design issue [Design Issues]

posted by jag009  – NJ, 2019-12-13 23:26  – Posting: # 20973
Views: 1,919

Hi everyone,

Question, if one conducted a study comparing ER to an immediate release reference but not following the recommended dosage regimen of the IR. Example, as per product monograph IR is given every 4 hrs and the new ER is given every 8 hrs, but the guy designed the pk study comparing ER vs 2xIR with both give at time 0, The design is obviously wrong (due to IR dosing regimen) but would a regulatory body reject the study (assume the study pass the BE objective which is BE needed only for auc). A pivotal study not pilot.

PS, not me! Doing some due diligence..

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